i3 Statprobe
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i3 Statprobe Employees
Confidential March 2015 - June 2015
Novartis April 2013 - September 2014
Novartis November 2012 - September 2014
Novartis July 2011 - March 2013
i3 Statprobe January 2010 - June 2011
Cognizant Technology Solutions June 2008 - December 2009
Skills
Oracle Clinical, Data Management, Clinical Trials, Validation, Oncology, Clinical Data Management, CRF design, Clinical Research, Protocol, Software Documentation, ICH-GCP, SAS, ARGUS, User Acceptance Testing, Data Analysis, Clinical, Peer Mentoring, Drug Safety, Project Management, Employee Training, Subject Matter Experts, Clinical Laboratory..., Microsoft Excel, SOP Development, GCP
Education
Maharashtra Institute of Technology 2004 — 2008
Bachelor of Pharmacy (B.Pharm.), Pharmaceticals
University of Pune 2004 — 2008
Bachelor of Pharmacy (BPharm), Pharmaceutical Sciences
Founder & CEO, Is Disease Hereditary 2014 - Present
Self 2007 - Present
Wildlife Research Institute 2010 - December 2013
i3 Statprobe September 2009 - February 2011
Wolters Kluwer Health (US and New Zealand) 1996 - 2006
Hannibal Regional Hospital May 1995 - April 1996
Creighton University, Colleges of Medicine and Pharmacy 1992 - 1994
University of South Alabama, College of Medicine 1984 - 1987
Skills
Research, Technical Writing, Public Speaking, Healthcare, Editing, Quality Assurance, Management, Entrepreneurship, SaaS, Healthcare Information..., Data Analysis, Databases, Software Development, Microsoft Office, Software Project..., Nutrition, HTML, Medical Research, Wildlife Conservation, Wildlife Photography, Macro Photography, Program Management, Clinical Research, Hospitals, Strategic Planning, Medicine
Education
Creighton University 1991 — 1995
Doctor of Pharmacy (PharmD) - cum laude, with a focus in Drug Information & Ambulatory Care
University of Auckland 2001 — 2001
Post-Graduate Studies, Clinical Epidemiology & Evidence-Based Healthcare
University of South Alabama 1983 — 1987
Bachelor of Science (BSc), Biology, minor in chemistry
Novartis Oncology February 2014 - Present
Indiana University August 2013 - January 2014
Boehringer Ingelheim May 2013 - August 2013
IUPUI August 2012 - May 2013
Cytel May 2012 - August 2012
Indiana University July 2010 - May 2012
Ranbaxy April 2008 - August 2009
i3 Statprobe April 2007 - April 2008
Ranbaxy March 2006 - April 2007
Skills
Statistics, Biostatistics, Functional Data Analysis, CART, Bootstrapping, Spectroscopy, SAS, LaTeX, R, WinBUGS, Survival Analysis, Data Analysis, Clinical Trials, Clinical Research, Logistic Regression, Clinical Development, Statistical Modeling, CRO, SAS Programming, Pharmaceutical Industry
Education
Indiana University School of Medicine 2009 — 2014
PhD, Biostatistics, 3.973
Indian Agricultural Research Institute 2003 — 2005
M.Sc., Agricultural Statistics, 8.73
Uttar Banga Krishni Viswavidyalaya 1999 — 2003
B.Sc., Agriculture, 8.42
Quintiles September 2012 - Present
i3 Statprobe October 2010 - September 2012
Warner Chilcott (Acquired P&G Pharma.) November 2009 - July 2010
P&G September 2007 - October 2009
Skills
Clinical Trials, Regulatory Submissions, Pharmaceutical Industry, CRO, Drug Development, SAS, Biostatistics, Clinical Development, Oncology
Education
University of Cincinnati 1999 — 2001
MS, Applied Statistics
i3 Statprobe Associate DirectorPharmaNet/i3 Strategic ResourcingJune 2012 - Present
Skills
CRO, Clinical Trials, Pharmaceutical Industry, GCP, CTMS, Oncology, 21 CFR Part 11, Data Management, Sop, ICH-GCP, Validation, FDA, Oracle Clinical, Biotechnology, CDISC, Regulatory Submissions
Education
Eastern Kentucky University
BioMarin Pharmaceutical Inc. August 2013 - Present
PharmaSUG 2008 - Present
Theorem Clinical Research January 2012 - August 2013
i3 Statprobe November 2010 - January 2012
PAREXEL July 2009 - November 2010
Kendle International 2007 - 2008
Skills
CRO, Clinical Trials, Clinical Data Management, Data Management, EDC, SAS Programming, Pharmaceutical Industry, Biostatistics, GCP, CDISC, Validation, SDTM, Oracle Clinical, SAS programming, 21 CFR Part 11, Statistical Programming, Oncology, SAS, Clinical Development, ICH-GCP, Clinical Research, Analytics
Education
North Carolina Central University 1984 — 1987
BS, Mathematics
BCforward April 2014 - Present
Seven Hopes United January 2013 - Present
Headbands of Hope January 2012 - Present
Children's Oncology Group February 2012 - October 2013
i3 Statprobe October 2010 - February 2012
Deborah Wood Associates March 2005 - September 2010
FunCityFinder.com August 2008 - January 2010
Skills
Editing, Healthcare, Writing, Research, Social Media, Wordpress, Publications, Marketing Communications, Word, Photoshop, Newsletters, Copy Editing, Photography, Proofreading, Copywriting, Microsoft Word, WordPress, Publishing, Press Releases
Education
DePauw University 2000 — 2004
Bachelor of Arts (B.A.), English Writing
PPD September 2014 - Present
Ockham Oncology April 2014 - September 2014
inVentiv Health Clinical November 2006 - April 2014
Consultant June 2002 - November 2006
i3 Statprobe May 2000 - June 2002
University of Michigan 1999 - 2000
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, English, Windows, Research, Outlook
Education
Loma Linda University 1995 — 1996
Master of Science (MS), Biostatisics
University of Calgary 1989 — 1994
Bachelor of Science (BS), Statistics
James fowler
Clovis Oncology September 2015 - Present
Santen November 2014 - September 2015
Onyx Pharmaceuticals January 2013 - October 2014
Genomic Health June 2012 - December 2012
Cerus 2011 - October 2012
i3 Statprobe November 2009 - September 2011
CG Therapeutics November 2008 - December 2009
Epigenomics AG 2007 - 2008
Illumigen Biosciences, Inc. March 2005 - September 2007
Affymetrix January 2003 - November 2003
Skills
Biostatistics, Clinical Trials, SAS, R, Statistical Computing, Genomics, Clinical Research, Clinical Development, S-Plus, SQL, Oncology, Drug Development, SAS MACRO, STAT, ODS,..., Java, Biomarker Discovery, Statistics, Bioinformatics, Biomarkers, CDISC, Biotechnology
Education
University of California, Berkeley 2001 — 2004
Masters, Biostatistics
University of California, Los Angeles 1988 — 1991
Ph.D., Systematic Musicology
University of California, Los Angeles 1986 — 1988
Master of Arts (M.A.), Musicology and Ethnomusicology
UCLA 1981 — 1986
BA, Summa cum laude, Music
inVentiv Health Clinical November 2013 - Present
inVentiv Health Clinical April 2012 - November 2013
Indiana University Health June 2011 - April 2012
i3 Statprobe October 2010 - June 2011
Eli Lilly and Company April 2007 - October 2010
Eli Lilly and Company May 2006 - April 2007
Eli Lilly and Company April 2005 - April 2006
Eli Lilly and Company - The Lilly Clinic February 2002 - March 2005
Eli Lilly and Company September 2000 - January 2002
Eli Lilly and Company August 1999 - September 2000
Skills
Project/Program..., Organizational Change, Change Management, Vendor Management, OCM, Forecasting, IT Service Management, ITIL, Process Improvement, Business Analysis, Project Planning, Problem Solving, IT Management, OCP, ERP, Management, Computer System..., Relationship Management, Six Sigma, Pharmaceutical Industry, Project Management, Cross-functional Team..., Integration, Business Process..., Project Portfolio..., PMP, SDLC, SAP, Business Process, Leadership, Program Management, Business Development, Team Management, Change Control, Project Delivery, Data Analysis, GxP, Business Strategy, Strategic Planning, Validation, Data Management, PMO, Outsourcing, Resource Management, Clinical Trials, Requirements Gathering, Performance Management, Software Project..., Clinical Data Management, CRO
Education
Ball State University 1998 — 1999
Master of Science, Information and Communication Sciences; Center for Information and Communication Sciences; CICS
Ball State University 1994 — 1998
Bachelor of Arts, Telecommunications - Corporate Video
Abbott Diabetes Care January 2013 - Present
Pfizer April 2010 - January 2013
i3 Statprobe November 2008 - April 2010
i3 Statprobe 2008 - 2008
PPD 2005 - 2008
Skills
Inform, EDC, CRF design, Oracle Clinical, Clinical Data Management, Medidata, GCP, CRO, CDISC, Clinical Trials, Clinical Development, Clinical Data, CTMS, MedDRA, 21 CFR Part 11, SDTM, ICH-GCP, Data Management, Therapeutic Areas
Education
Arizona State University 2013 — 2016
Masters of Science, Clinical Research Management
Indiana University Bloomington 1997 — 2005
Computer Science
Atterocor, Inc. October 2013 - February 2014
Clinipace Worldwide (formerly Paragon Biomedical) September 2012 - April 2013
Paragon Biomedical September 2007 - August 2012
i3 Statprobe March 1998 - August 2007
Accumed International, Inc. January 1997 - February 1998
Difco Laboratories September 1990 - December 1996
St. Jude Children's Research Hospital September 1988 - August 1990
University of Tennessee Health Science Center September 1985 - August 1988
Skills
CRO, Clinical Trials, Clinical Development, CTMS, EDC, Clinical Monitoring, Pharmaceutical Industry, GCP, Therapeutic Areas, Clinical Research, FDA, Oncology, Diabetes, Vendor Management, Data Management, Oracle Clinical, Medical Writing, Infectious Diseases, Clinical Data Management, Biostatistics, Medical Devices, ICH-GCP, Regulatory Affairs, Biotechnology
Education
University of Minnesota 1980 — 1985
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Hope College 1976 — 1980
BA, Biology
Roche October 2014 - Present
Roche October 2012 - October 2014
Roche Pharmaceuticals May 2012 - October 2014
Roche December 2011 - September 2012
i3 Statprobe February 2011 - December 2011
i3 Statprobe January 2010 - February 2011
i3 Statprobe March 2009 - January 2010
i3 Statprobe June 2008 - April 2009
i3 Research February 2007 - June 2008
AstraZeneca Canada June 2003 - February 2007
Skills
Protocol Development, Medical Writing, Clinical, Therapeutic areas, EDC, 21 CFR Part 11, Clinical Research, Scientific..., Manuscript, Protocol, GCP, Therapeutic Areas, Regulatory Documentation, Data Management, Clinical Development, Clinical Trials, NDA, Oncology, Clinical Study Design, CRO
Education
University of Toronto 1995 — 1997
MSc, Neuropsychiatry & Sleep physiology
Brock University 1990 — 1995
(Hon)BSc, Neuroscience
Mapi Group Associate DirectorMapi GroupJuly 2015 - Present
Mapi Group December 2013 - July 2015
inVentiv Health June 2012 - December 2013
i3 statprobe March 2011 - June 2012
i3 statprobe March 2008 - March 2011
SciAn Services May 2005 - February 2008
SciAn Services September 2000 - May 2005
Skills
CDISC, Clinical Data Management, Statistical Programming, Biostatistics, SAS programming, Oracle Clinical, Clinical Trials, EDC, CRO, SAS, Clinical Development, Clinical Study Design, GCP, SDTM, Statistics, SAS Programming
Education
Carleton University
BSc, Mathematics
York University
MSc, Statistics
Triangle Project Management, LLC December 2014 - Present
Rotary International 1981 - Present
Duke Clinical Research Institute August 2012 - November 2014
Duke Clinical Research Institute July 2013 - December 2013
Duke Clinical Research Institute March 2013 - December 2013
Grifols September 2005 - August 2012
Quintiles March 2003 - September 2005
I3 STATPROBE January 2001 - March 2003
Holke Press, Inc. March 1996 - December 2000
Mallinckrodt Veterinary July 1981 - November 1993
Skills
Clinical Development, Clinical Trials, CRO, Pharmaceutical Industry, CTMS, EDC, Biotechnology, Clinical Research, GCP, Oncology, Therapeutic Areas, Validation, Drug Development, Life Sciences, GLP, Technology Transfer, Data Management, Project Management, FDA, Sop, Regulatory Affairs, IND, Risk Management, Clinical Operations, Lifesciences, Regulatory Submissions, 21 CFR Part 11, R&D, Biopharmaceuticals, ICH-GCP, GMP, Program Management
Education
Stanford University School of Medicine 1974 — 1975
Post Doctoral Fellow
The University of Glasgow 1967 — 1974
BSc (1st Class Hons), PhD
Randstad Pharma February 2013 - June 2015
Advanced Clinical January 2011 - January 2013
Baxter Healthcare January 2008 - November 2010
Baxter Healthcare May 2007 - January 2008
University of Michigan Medical Center January 2007 - May 2007
i3 Statprobe January 2006 - December 2006
Skills
Oncology, CRO, Clinical Data Management, Oracle Clinical, Clinical Trials, GCP, EDC, Infectious Diseases, Pharmaceutical Industry, Clinical Research, Data Management, 21 CFR Part 11, CTMS, Clinical Development, ICH-GCP, SOP
Education
Eastern Michigan University 2004 — 2005
Graduate Certificate, Clinical Research Administration
Michigan State University 1998 — 2002
Hartland High 1994 — 1998
inVentiv Health May 2011 - Present
i3 Statprobe January 2008 - May 2011
Kendle International Inc. December 2004 - October 2007
Kendle International Inc. July 1999 - December 2004
Skills
Pharmaceutical Industry, Clinical Research, Oncology, CRO, SAS, Biotechnology, FDA, Microsoft Office, Validation, Leadership
Education
University of Cincinnati
Master of Science (MS), Mathematics
East China Normal University
Master of Science (M.S.)
East China Normal University
B.A., Chemistry
Freelance January 2008 - Present
i3 Statprobe May 2007 - January 2008
PPD March 2006 - April 2007
PPD January 2004 - March 2006
PPD April 2002 - December 2003
PPD June 2000 - March 2002
PPD August 1997 - May 2000
Skills
CRO, Medical Writing, Regulatory Submissions, Sop, Protocol, Pharmaceutical Industry, GCP, Clinical Trials, Clinical Research, Clinical Development, CTMS
Education
East Carolina University
Bachelor of Science (BS), Biology, General
BioClinica June 2009 - Present
Gerson Lehrman Group April 2011 - Present
IXICO July 2008 - 2009
i3 Statprobe September 2005 - July 2008
CentraLabS Clinical Research November 2003 - September 2005
Quintiles GDRU November 1999 - November 2003
Unilabs, UCTi (now ICON) September 1995 - October 1999
Skills
Clinical Trials, CRO, Clinical, Medical Writing, Data Management, Clinical Research, Medical Imaging, Cardiac Safety, Global Business..., Business Development, CTMS, Biotechnology, Oncology, Lifesciences, Clinical Development, Medical Devices, Pharmaceutical Industry, Cardiology, EDC, GCP, Regulatory Affairs, Drug Development, Business Strategy, Strategic Partnerships, Biomarkers, R, Life Sciences
Education
Kingston University 2002 — 2004
MBA, Business
North East Surrey College of Technology (NESCOT) 1992 — 1993
MSc, Biomedical Sciences
University of Leeds 1989 — 1992
BSc, Physiology
Quintiles November 2014 - Present
Quintiles July 2011 - November 2014
i3 Statprobe January 2010 - July 2011
i3 Statprobe December 2006 - January 2010
Pfizer October 2004 - December 2006
i3 Statprobe December 1999 - October 2004
The Ohio State University May 1999 - December 1999
The Ohio State University June 1997 - May 1999
Belaruski Dziarzhauny Universitet July 1994 - May 1997
Skills
Statistics, Biostatistics, Regulatory Submissions, EDC, Clinical Trials, Infectious Diseases, 21 CFR Part 11, CRO, Oncology, Drug Development, Lifesciences, SAS programming, Clinical Development, Regulatory Affairs, R, Clinical Research, Clinical Data Management, Survival Analysis, Pharmaceutical Industry, SAS, Analysis, Data Management, Biotechnology, FDA, Validation, CTMS, GCP, Project Management, Protocol, Data Analysis, Medical Writing, Market Research, Therapeutic Areas
Education
University of Michigan 2006 — 2011
Doctor of Philosophy (PhD), Statistics
The Ohio State University 1997 — 2000
MS, Statistics
Belaruski Dziarzhauny Universitet 1989 — 1994
MS, Science Mathematics
Iceni Tea, LLC September 2008 - Present
Pfizer May 1999 - June 2007
i3 Statprobe March 1998 - May 1999
Meijer 1996 - 1998
Skills
Security, Training, Risk Assessment, Food, Entrepreneurship, Marketing Strategy
Education
Concordia University-Ann Arbor 2001 — 2003
Business Management
Ann Arbor Huron High School 1970 — 1974
basic, art
ExecuPharm June 2015 - Present
MMS Holdings Inc. June 2013 - June 2015
Allergan February 2011 - October 2012
i3statprobe September 2008 - October 2010
i3 Statprobe September 2007 - September 2008
i3Statprobe June 2006 - September 2007
Pfizer Global R & D 1996 - 2006
Skills
SAS, Oracle Clinical, CDISC, CRO, Clinical Trials, EDC, Clinical Data Management, Clinical Research, Medidata, Vendor Management, GCP, CTMS, Clinical Development, Pharmaceutical Industry, Data Management, 21 CFR Part 11, Oncology, ICH-GCP, Clinical Monitoring, Therapeutic Areas, Drug Development
Education
Alma College 1983 — 1987
BA, Management, Math, Computers
Boehringer Ingelheim Ltd. August 2011 - Present
Boehringer Ingelheim April 2011 - August 2011
Boehringer Ingelheim - Insourced through Brunel Multec Inc. November 2010 - April 2011
i3 Statprobe March 2010 - November 2010
Sanofi Pasteur Ltd December 2006 - March 2010
Sanofi Aventis June 2001 - September 2007
sanofi-aventis Canada Inc 2001 - 2007
Skills
Clinical Development, Project Management, CTMS, GCP, Clinical Trials, Medical Writing, CRO, EDC, ICH-GCP
Education
McMaster University 1991 — 1994
MSc., Experimental Psychology
Henry Ford Wyandotte Downriver Cardiology October 2011 - Present
ER One 2010 - October 2011
CMAC Transportation 2003 - 2008
i3 Statprobe 2002 - 2003
Cardinal Services 2001 - 2002
City of Dearborn 1996 - 2000
Education
University of Detroit Mercy 2007 — 2010
MS, Physician Assistant
University of Michigan-Dearborn 2001 — 2003
BA, Psychology
Michigan State University 1998 — 2001
Quintiles September 2013 - Present
Quintiles September 2011 - August 2013
Premier Research April 2010 - September 2011
PharmaNet Development Group, Inc. February 2006 - March 2008
I3 Statprobe September 2004 - January 2006
Quintiles July 2000 - September 2004
Skills
EDC, Oracle Clinical, Clinical Data Management, CRO, Data Management, GCP, ICH-GCP, eTMF, Inform, Fortis, OC RDC, Microsoft Excel, Microsoft Word, Outlook, Automotive Parts, Computer Repair, Software Installation, Basketball Coaching, Service Focused, Therapeutic Areas, Research, Process Improvement, Database Administration, Protocol, Databases, Training, Software Documentation, Quality Assurance, Healthcare, Clinical Research, SharePoint, Data Analysis, FDA, Pharmaceutical Industry, Biotechnology, Microsoft Office, Validation, CRF design, Project Management, Program Management, Management, Clinical Trials, Sop, Troubleshooting, Medidata, Access, Data Entry, 21 CFR Part 11, Data Validation, Leadership
Education
Mycomputercareer.com 2006 — 2007
A+, MCP, MCTS, IT Support and Networking
Campbell University 1983 — 1986
Physical Education
Swansboro High School
i3 Statprobe September 2010 - November 2013
i3 Statprobe August 2007 - February 2010
MDS Pharma Services May 2006 - August 2007
Skills
Clinical Data Management, Oracle Clinical, Clinical Trials, GCP, CRO
Education
University of Guelph 2000 — 2004
BSc., Biological Science
Freelance Medical Communications 2013 - Present
Bioscript Science 2010 - 2013
i3 Statprobe 2008 - 2010
Clearly Stated Scientific Writing and Editing 2005 - 2008
Temple University Medical School 2004 - 2006
Adjunct Professor 1997 - 2006
Skills
Oncology, Cancer, Diabetes, Cell Culture, Therapeutic Areas, Cell, Medical Communications, Data Analysis, Cardiovascular Disease, Manuscript, Editing, Medicine, Teaching, Training, Science
Education
Temple University School of Medicine 1998 — 2004
Ph.D., Biochemistry
University of Pennsylvania
BA, Biology
Quintiles August 2013 - Present
Quintiles March 2011 - August 2013
i3 Statprobe May 2009 - March 2011
C Dark Consulting November 2008 - May 2009
Clarkston Consulting January 2008 - November 2008
Statistics and Data Corporation July 2006 - January 2008
SCDM January 2005 - December 2007
Omnicare July 2005 - April 2006
Constella Group July 2001 - July 2005
Constella Group June 2001 - June 2005
Skills
Data Management, Project Management, CRM, Relationship Management, Continuous Improvement, Biostatistics, Organizational..., Regulations, Quality Improvement, Income Statement, Clinical Trials, CRO, Pharmaceutical Industry, EDC, Clinical Development, GCP, Clinical Data Management, Inform, Strategy, Drug Development, Clinical Research, Leadership, Global Client Management, CTMS, Business Process..., Cross-functional Team..., 21 CFR Part 11, Validation, Management, FDA, Program Management, Sop, CRF design, CDISC, Oracle Clinical, Business Development, ICH-GCP, Regulatory Affairs, Regulatory Submissions, Lifesciences, SAS, Oncology, Biotechnology, Infectious Diseases, Manage Client..., Clinical Study Design, Operations Management, Life Sciences, Strategic Planning, Consulting
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2006 — 2007
Masters, Business Administration
North Carolina State University 1990 — 1995
BS, Statistics
North Carolina State University 1991 — 1994
Bachelors of Science, Statistics
INC Research December 2014 - Present
INC Research (formerly Kendle International) 2011 - December 2014
Kendle International 2008 - 2011
i3 Statprobe 2006 - 2008
i3 Statprobe 2005 - 2006
PPD January 2003 - July 2004
PPD 1999 - 2002
PPD 1997 - 1999
WakeMed June 1996 - July 1997
PPD 1994 - 1996
Education
North Carolina State University
Bachelor of Arts, English
inVentiv Health May 2007 - Present
i3 Statprobe May 2007 - May 2011
inVentiv Health 2010 - 2011
freelance 2007 - 2007
MDS Pharma Services 2001 - 2007
Skills
CRO, Medical Writing, Pharmaceutical Industry, Clinical Development, GCP, Clinical Trials, Medicine, IND, Regulatory Submissions, Protocol, Drug Development
Education
Concordia University 1994 — 1996
Fine Arts (Painting & Drawing)
Memorial University of Newfoundland 1984 — 1988
BA, English & Russian Joint Degree
Memorial University of Newfoundland 1980 — 1984
BSc, Biology
Home September 2011 - Present
ICON Clinical Research September 2004 - September 2011
i3 Statprobe 2001 - 2004
ICON 1999 - 2001
Skills
Clinical Research, EDC, Clinical Development, Clinical Monitoring, Clinical Trials, CRO, Clinical Data Management, Clinical Research..., GCP, ICH-GCP, Oncology, Regulatory Submissions, Therapeutic Areas, CTMS, Pharmaceutical Industry
Education
Eastern Michigan University 2005 — 2005
Clinical Research
University of Alabama in Huntsville 1994 — 1999
Celgene August 2012 - February 2013
Actelion October 2009 - January 2010
i3 statprobe 2010 - 2010
AstraZeneca 2008 - 2009
Skills
Clinical Trials, Data Entry, Clinical Research, Data Management, Oncology, Pharmaceuticals, Clinical Data Management, SOP, FDA, PowerPoint, Excel, Microsoft Office, Documentation, Clinical Development, GCP, Outlook, Clinical Trial..., Word, CRO, Customer Service, Regulatory Submissions, Gastroenterology
Education
University of Delaware 2010 — 2010
clinical trials manager
Arcadia University 2002 — 2006
Bachelor, Biology & Italian
inVentiv Health Clinical May 2014 - Present
inVentiv Health Clinical January 2011 - May 2014
i3 Statprobe July 2008 - December 2010
Favrille April 2007 - June 2008
Elan Pharmaceuticals April 2004 - December 2006
PAREXEL April 2002 - February 2004
Skills
CRO, Clinical Data Management, Oracle Clinical, SAE Reconciliation, Inform, CRF design, Sop, Data Management, Clinical Research, Biostatistics, Clinical Trials, Validation
Education
UCSD Extension 2003 — 2003
Data Modeling and Relational Database Design
University of California, San Diego 1994 — 1999
B.S., Biochemistry/Cell Biology
Harding University July 2015 - Present
Harding University July 2012 - July 2015
Harding University June 2010 - July 2012
Paragon Biomedical August 2006 - January 2010
Paragon Biomedical August 2006 - March 2008
i3 Statprobe 2005 - 2006
i3 Statprobe 1999 - 2005
i3 Statprobe 1997 - 1999
i3 Statprobe 1995 - 1996
Skills
CRO, Clinical Trials, Strategic Planning, Customer Relations, Oncology, Biotechnology, Clinical Research, Pharmaceutical Industry, Medical Devices, Lifesciences, Business Development, Budgets, Project Management, Infectious Diseases, Marketing, CTMS, Management, Clinical Development, Data Management, New Business Development, Team Leadership, Diabetes, Central Nervous System, Business Strategy, Fundraising, Higher Education
Education
Creighton University 2002 — 2004
MBA, Business Administration
Creighton University's Heider College of Business 2002 — 2004
Master of Business Administration (MBA)
Harding University 1992 — 1996
BBA, Accounting
Health Services Advisory Group, Inc. (HSAG) February 2015 - Present
FMQAI March 2014 - Present
FMQAI April 2013 - September 2013
i3 Statprobe September 2009 - February 2011
Advanced Research Corporation May 2007 - March 2009
Kelly Scientific Resources January 2003 - April 2003
Merck & Co December 1977 - December 2002
Skills
Validation, Pharmaceutical Industry, FDA, Clinical Trials, Medical Writing, Adobe Acrobat, Sop, Quality Assurance
Education
Drexel University College of Medicine
MS, Microbiology-Medial Technology
Gwynedd Mercy University
BA, Biology/Chemistry
MMS Holdings Inc. August 2015 - Present
YourEncore June 2013 - January 2015
Aastrom Biosciences November 2012 - July 2014
Accumed Systems January 2014 - April 2014
University of Michigan, Department of Biostatistics June 2008 - July 2013
i3 Statprobe August 2007 - May 2008
Pfizer Global Research and Development, Clinical Biostatistics February 2004 - August 2007
Parke-Davis Pharmaceutical Research (became Pfizer Global Research and Development in June 2000), Bi November 1998 - January 2004
Parke-Davis Pharmaceutical Research, Biometrics Department. Senior Statistician II September 1995 - October 1998
Parke-Davis Pharmaceutical Research, Biometrics Department September 1992 - August 1995
Skills
Bayesian statistics, Bioequivalence, Assay validation, Noncompartmental..., Familiarity with..., Proof of concept studies, Single- and..., Drug interaction studies, Linear and nonlinear..., Sample sizing of..., Statistics, Logistic Regression, Clinical Study Design, Clinical Development, Assay Development, Experimental Design, Clinical Trials, Biotechnology, Oncology, GCP, Life Sciences, CRO, Data Review, Statistical Programming, Drug Development, Survival Analysis, Data Quality, Pharmaceutical Industry, Biostatistics, Phase I, FDA, Clinical Pharmacology, Clinical Research
Education
The Ohio State University
Ph.D, Statistics
The Ohio State University
M.S, Statistics
Miami University
B.A, Zoology
Hayflinger Analytic Services January 2008 - Present
Observational Medical Outcomes Partnership (OMOP) July 2009 - February 2013
Lovelace Respiratory Research Institute May 2010 - April 2011
GlaxoSmithKline March 2003 - January 2008
Department of Health and Human Services October 2000 - April 2003
Palmetto GBA April 1999 - October 2000
i3 Statprobe 1998 - 1999
Skills
Epidemiology, Health Economics, Outcomes Research, Biostatistics, Health Outcomes, SAS Programming, Medical Coding, ICD-9, CPT-4, NDC, Comparative..., Statistical Modeling, Health Services Research, Data Analysis, SAS programming, Informatics, SAS, CRO, Clinical Data Management, Data Management, Statistical Programming, Analysis, Public Health, Infectious Diseases, Pharmacoeconomics, Pharmacovigilance, CPT, Statistics, Analytics, Pharmacoepidemiology, Drug Development, Pharmaceutical Industry, Healthcare
Education
University of Michigan 1997 — 1999
MS, Biostatistics
State University of New York College at Brockport 1991 — 1995
BS, Biology, Mathematics
Amgen February 2015 - Present
Amgen, Inc January 2012 - Present
Amgen, Inc January 2008 - December 2011
Amgen, Inc October 2006 - December 2007
i3 Statprobe March 2003 - September 2006
STATPROBE, Inc January 2002 - March 2003
Quintiles Pacific, Inc January 2000 - January 2001
Quintiles Pacific, Inc January 1999 - January 2000
Quintiles Pacific, Inc January 1998 - January 1999
Skills
Clinical Data Management, CRO, Clinical Trials, Oracle Clinical, Data Management, Software Documentation, Sop, Oncology, FDA, Validation, Project Management, SAS
Education
Santa Clara University 1994 — 1998
B.S, Combined Sciences
inVentiv Health Clinical August 2015 - Present
Xerox November 2014 - August 2015
DOCS Global (formerly ClinForce) July 2012 - November 2013
Astron Consulting August 2011 - January 2012
Volt February 2011 - March 2011
i3 Statprobe November 2008 - January 2011
Eli Lilly May 2005 - November 2008
Eli Lilly March 2004 - May 2005
Eli Lilly December 2001 - March 2004
Kelly Scientific Resources August 2000 - November 2001
Skills
Clinical Trials, Pharmaceutical Industry, CRO, Clinical Research, Oncology, GCP, CTMS, Data Management, Clinical Development, FDA, Inform, Neuroscience, Biotechnology, ICH-GCP, Drug Development, Protocol, Clinical Study Design, EDC, CRF design, Clinical Data Management, 21 CFR Part 11, Life Sciences, Therapeutic Areas, Pharmacovigilance, SOP, Diabetes, Medical Devices
Education
Indiana University Bloomington 1991 — 1996
BA, Biology
Anderson High School
Diploma, College Prepatory
ThotWave Technologies, LLC. November 2002 - Present
Duke University Health System 2012 - 2013
SAS 1986 - 2013
North Carolina State University 2009 - 2010
i3 Statprobe 1999 - 2002
ASG 1996 - 1999
The Gallup Organization 1993 - 1995
Skills
Public Speaking, Predictive Modeling, SAS, Predictive Analytics, Informatics, Data Analysis, Decision Support, Healthcare Information..., Data Management, Data Mining, management consulting, Strategy consulting, Disease Management, Evidence-based Medicine, JCAHO, Pay for Performance, Core Measures, Business Intelligence, Management Consulting, Data Warehousing, Data Modeling, EHR, Business Analysis, Enterprise Software, ETL, Statistics, Clinical Research, SAS programming, Clinical Trials, Data Integration, Analytics, CRO, Databases, Programming, Management, Business Analytics, Software Development, Statistical Modeling, Professional Services, Project Management, Big Data, Consulting, Healthcare, Segmentation, SAS Programming
Education
Duke University - Fuqua School of Business 2012 — 2013
Masters of Management in Clinical Informatics, Healthcare Analytics and Performance Management
The University of Georgia 1989 — 1991
PhD Candidate, Social Psychology
University of California, Santa Cruz 1986 — 1988
B.A., Psychology, Social Psychology, Quantitative Methods
Eli Lilly and Company March 2013 - Present
Eli Lilly and Company November 2011 - February 2013
i3 Statprobe October 2008 - November 2011
Eli Lilly June 2003 - October 2008
MedFocus November 2001 - May 2003
Indiana University School of Medicine May 1999 - November 2001
Education
University of Indianapolis 1998 — 2001
BS, Human Biology
inVentiv Health October 2012 - Present
i3 Statprobe February 2010 - November 2012
i3 Statprobe April 2007 - February 2010
Wyeth 2004 - 2005
Skills
CDISC, CRO, Clinical Research, SAS programming
Education
Michigan State University 2004 — 2006
M.S., Applied Statistics
University of Michigan 1999 — 2003
B.S, Statistics
Kmax Stat Programming, Inc. April 2010 - Present
Comprehensive Clinical Development July 2011 - April 2012
Rho 2010 - 2011
Omnicare Clinical Research May 2009 - April 2010
i3 Statprobe September 2006 - April 2009
PPD 2002 - 2005
GSK 1988 - 1996
Skills
CDISC, CRO, Statistical Programming, Clinical Trials, SAS, SAS programming, SDTM, Project Management, Client Liaison, Clinical Research, Consulting, Self-starter, Corporate Communications, Pharmaceutical Industry, 21 CFR Part 11, Clinical Development, Clinical Data Management, GCP, Data Management, Drug Development, Validation
Education
North Carolina State University
BS, Mathematics
Peace College
AA
Milliman October 2011 - Present
i3 Statprobe February 2009 - October 2011
Health Care Excel April 2006 - December 2008
UCSD Library 1991 - 2000
Skills
Medical Writing, Clinical Research, Clinical Trials, Healthcare, Access, Regulatory Submissions, Pharmaceutical Industry, Healthcare Management, Oncology, Policy, Medicaid, Medicare, Medicine, Healthcare Information..., Medical Research
Education
Indiana University-Purdue University at Indianapolis 2002 — 2005
MLS, Library and Information Science
East Hartford High School
East Hartford High School
Loyola University New Orleans
B.A., English
The Downers Grove First United Methodist Church June 2014 - Present
Platinum Restoration January 2013 - June 2014
Chick-fil-A September 2012 - January 2013
Westminster Presbyterian Church July 2010 - May 2012
Grace United Methodist Church August 2008 - March 2010
Milan Free Methodist Church April 2006 - June 2008
Hillsdale Free Methodist Church September 2000 - April 2006
i3 Statprobe July 1998 - September 2000
Clintrials Research September 1997 - June 1998
PAREXEL January 1997 - August 1997
Skills
Program Management, Youth Ministry, Discipleship, Preaching, Theology, Pastoral Care, Biblical Studies, Pastoral Counseling, Religion, Community Outreach, Volunteer Management, Missions, Spiritual Direction, Student Ministry, Church Events, Public Speaking, Teaching, Pastoral, Pastoring, Leadership, Religious Studies, Conflict Resolution, Program Development, Church Administration, Church Growth, Youth Mentoring, Apologetics, Evangelism, Psychotherapy, Bible, Discipleship Training, Ministry Development, Non-profit..., Bible Study, Youth Development, Community Organizing, Chaplaincy, Expository Preaching, Ministry Leadership, Practical Theology, Project Management, Restoration, Water Damage Restoration, Volunteer Training, Youth Leadership, Networking, Adults, Staff Development, Fundraising, Leadership Development
Education
Concordia University-River Forest 2012 — 2014
Master of Arts (M.A.), Counselor Education/School Counseling and Guidance Services
Asbury Theological Seminary 1997 — 2009
MA, Youth Ministry
Greenville College 1987 — 1991
Bachelor of Science (B.S.), Social Studies Teacher Education
Lane Tech 1982 — 1987
High School Diploma, Math/Science
Intercept Pharmaceuticals July 2015 - Present
Intercept Pharmaceuticals December 2014 - June 2015
Profil Institute for Clinical Research, Inc. August 2011 - November 2014
i3 Statprobe September 2009 - August 2011
i3 Statprobe July 2006 - September 2009
i3 Statprobe March 2005 - June 2006
SkyePharma, Inc. March 2004 - March 2005
Skills
Oracle Clinical, EDC, Clinical Data Management, Clinical Trials, Data Management, Clinical Research, GCP, CRO
Education
University of California, San Diego 2002 — 2004
BS, Biology
California State University-Northridge 1998 — 2001
Biology
ACADIA Pharmaceuticals Inc. January 2015 - Present
ACADIA Pharmaceuticals June 2012 - December 2014
Pharmaceutical companies July 2007 - May 2012
i3 Statprobe September 2005 - July 2007
ProSanos Corporation March 2004 - September 2005
Agouron Pharmaceutical / Pfizer April 1998 - March 2004
Alliance Pharmaceuticals September 1997 - April 1998
Biogen Idec November 1995 - September 1997
Skills
Biostatistics, Clinical Trials, Clinical Research, CRO, Clinical Development, Statistics, SAS programming, Drug Development, Pharmaceutical Industry
Education
San Diego State University-California State University 1993 — 1995
MPH, Biostatistics
University of California, Los Angeles - Fielding School of Public Health 1989 — 1991
National Taiwan University 1985 — 1989
BS, Agriculture
GE Aviation January 2010 - Present
Chrysler Financial November 2007 - January 2010
Chrysler Financial September 2006 - October 2007
Chrysler Financial May 2005 - August 2006
Sircon Corporation August 2000 - August 2003
i3 Statprobe January 1998 - July 2000
Skills
Business Intelligence, Project Management, Analysis, Cross-functional Team..., Forecasting, Process Improvement, Risk Management, Strategy, Business Process..., Financial Analysis, Management, Strategic Planning
Education
Michigan State University - The Eli Broad College of Business 2003 — 2005
MBA, Finance
University of Michigan 1993 — 1996
BA, Social Psychology
Audatex 2003 - Present
i3 Statprobe December 1999 - April 2003
Skills
Servers, Windows, Troubleshooting, Documentation, Operating Systems, Hardware, Software Documentation, Networking, VMware, Windows Server, Active Directory, Disaster Recovery, DNS, IIS, CCNA, Citrix, Data Center, Virtualization, Windows 7, Technical Support, System Administration
Education
Excelsior College 2000 — 2008
Bachelor of Science, Psychology, Computer Science
Delta College
Associate of Arts, Liberal Arts
Pinnacle Solutions, Inc. December 1996 - Present
Eli Lilly and Co. 1996 - 2000
i3 Statprobe 1995 - 1996
Skills
SAS, Business Intelligence, Testing, Technical Writing, Validation, Project Management, Custom Software..., Analytics, Data Analysis, SDLC, Databases, Data Mining, Integration, Data Integration, Statistics, Predictive Analytics, SQL, Data Warehousing, ETL, Big Data, Data Management, Project Planning, SAS programming, Data Modeling, Strategic Planning, Unix, Business Process, Analysis, Requirements Gathering, Business Analytics, .NET, Predictive Modeling, Software Development, Programming, Database Design, Requirements Analysis, Data Visualization, Business Analysis
Education
Kalamazoo College 1986 — 1990
Bachelors, Computer Science
Kalamazoo College 1986 — 1990
Bachelors, Mathematics
Kalamazoo Loy Norrix
i3 Statprobe Chief Operating OfficerinVentiv Health ClinicalApril 2014 - Present
i3 2006 - April 2011
Kendle International 1996 - 2006
Abbott Laboratories 1993 - 1996
Education
Loyola University Chicago 1980 — 1984
inVentiv Health Clinical February 2013 - Present
PharmaNet-i3 June 2011 - February 2013
i3 Statprobe August 2010 - June 2011
IUPUI 2008 - 2011
Skills
SAS programming, SAS, Clinical Trials, Statistical Programming, Validation, CRO, Clinical Development, Infectious Diseases, GCP, 21 CFR Part 11, ICH-GCP, Pharmaceutical Industry
Education
Indiana University-Purdue University at Indianapolis 2008 — 2013
2013, Applied statistics
NIIT Beximco System Ltd. 1998 — 2000
Higher Diploma
DIU, Dhaka Bangladesh 1994 — 2000
BSS and MSS, Economics, 1st class in MSS
BMHM High school, Doha-Qatar
AstraZeneca July 2014 - Present
JZK Consulting, LLC 2014 - Present
Nuron Biotech Inc August 2013 - September 2014
Applied Clinical Intelligence March 2012 - August 2013
InSightec August 2004 - March 2012
i3 Statprobe June 2002 - August 2004
ICON Clinical Research October 1998 - June 2002
Skills
Clinical Trials, FDA, Clinical Research, Regulatory Submissions, Regulatory Affairs, Quality Assurance, CTMS, Medical Imaging, GCP, Sop, Validation, CRO, EDC, Data Management, Clinical Monitoring, Oncology, Protocol, Medical Devices, Clinical Development, Biotechnology, Infectious Diseases, Pharmaceutical Industry
Education
East Stroudsburg University of Pennsylvania 1995 — 1996
MS, Cardiac Rehabilitation and Exercise Science
Towson University 1992 — 1996
Bachelor of Science (BS), Kinesiology and Exercise Science
OJR
Takeda Oncology 2012 - 2015
Takeda Oncology 2012 - 2015
Takeda Oncology 2012 - 2015
Takeda Oncology 2012 - 2014
Various clients April 2011 - August 2012
Eisai April 2009 - April 2011
sanofi-aventis April 2007 - March 2009
Forest Research Institute 2008 - 2008
Aspreva Pharmaceuticals 2006 - 2006
i3 Statprobe 2006 - 2006
Skills
Documentum, Provantis, Citrix, Lotus Notes, Outlook, Corel Office, MS Office Suite, LexisNexis, SigmaStat, Drug Development, Regulatory Affairs, GxP, IND, Strategy, Clinical Development, Microsoft Office, Medical Writing, Oncology, Clinical Trials, Regulatory Submissions, CRO, Biotechnology
Education
Montclair State University 2010 — 2012
Graduate Certificate, Molecular Biology
Hood College 2004 — 2005
Graduate Certificate, Regulatory Compliance
Montgomery College 2002 — 2004
Associate of Arts (AA), Biotechnology
University of Mumbai 1994 — 1999
Bachelor of Science (BSc), Microbiology and Biotechnology
Various companies August 2014 - Present
PPD May 2014 - August 2014
i3 Statprobe May 2010 - January 2013
Medical Information Source July 1997 - July 2009
Skills
Medical Writing, Oncology, Clinical Development
Education
Rutgers University-New Brunswick 1990 — 1996
MMS Holdings Inc. February 2013 - Present
Pharmanet/i3 April 2004 - January 2013
i3 Statprobe April 2004 - January 2013
i3 2004 - January 2013
Parke-Davis/Pfizer 1978 - 2004
Parke-Davis/Pfizer 1978 - 2004
Pfizer/PD 1978 - 2004
Pfizer Global Research & Development 1978 - 2004
Pfizer 1978 - 2004
Warner Lambert 1978 - 2004
Skills
Clinical Data Management, Drug Development, Clinical Development, Biostatistics, GCP, CRO, Oracle Clinical, Oncology, Clinical Trials, EDC, Pharmaceutical Industry, Therapeutic Areas, CDISC, CTMS, Protocol, Validation, Clinical Study Design, Regulatory Submissions, Medical Writing, FDA, Statistical Programming, SAS, 21 CFR Part 11, CRF design, Data Management, SDTM, Infectious Diseases, ICH-GCP, SAS programming
Education
Columbia University in the City of New York 1976 — 1978
MPH, Biostatistics
PAREXEL November 2014 - Present
PAREXEL December 2012 - October 2014
Keller Willams Realty August 2013 - August 2013
Best In Show Realty August 2008 - July 2013
PharmaNet/i3 Strategic Resourcing November 2011 - November 2012
i3 Statprobe November 2008 - September 2011
Eli Lilly February 2002 - October 2008
IMN Companies 2006 - 2008
Skills
Clinical Data Management, Data Management, Statistical Programming, CRO, CDISC, EDC, Clinical Trials, Pharmaceutical Industry, 21 CFR Part 11, SAS programming, GCP, Biotechnology, SAS, FDA, Clinical Development, Clinical Research, Biostatistics, Oncology, CTMS, Validation, Protocol
Education
Central Michigan University 1997 — 2001
Bachelor of Science in Business Administration, Management Information Systems, General, Magna cum Laude
vfm Editing & Quality Management June 2009 - Present
Kendle International 2008 - 2009
i3 Statprobe 2008 - 2008
Schwarz Biosciences 2005 - 2007
Duke Clinical Research Institute 2003 - 2005
Cisco Systems 1996 - 2003
Imonics 1995 - 1996
BNR 1991 - 1995
DG 1987 - 1990
U.S. Environmental Protection Agency 1985 - 1985
Skills
Proofreading, Editing, Editorial, Software Documentation, Publishing, Technical Writing, Medical Writing, Publications, Clinical Trials, Pharmaceutical Industry, FrameMaker, Writing, Regulatory Submissions, Copywriting, Regulatory Affairs, Manuscript, RoboHelp, Protocol, Healthcare, Adobe Acrobat
Education
Miami University 1983 — 1985
MTSC, Tech & Sci Communication
Western Michigan University 1976 — 1980
BA, English, French, journalism
valley
inVentiv Health Clinical December 2013 - Present
inVentiv Health Clinical June 2011 - December 2013
i3 Statprobe August 2010 - June 2011
i3 Statprobe June 2008 - July 2010
i3 Statprobe October 2006 - May 2008
Statprobe, Inc June 2005 - September 2006
Statprobe, Inc July 2002 - May 2005
Kalamazoo Center for Medical Studies/Michigan State University 2000 - 2002
Skills
Biostatistics, Statistics, CRO, Clinical Trials, SAS programming, Leadership, FDA, CDISC, Pharmaceutical Industry, Clinical Development, Medical Writing, EDC, Data Management, CTMS, GCP, Clinical Data Management, Therapeutic Areas, Statistical Programming, Drug Development, Regulatory Submissions, Protocol, 21 CFR Part 11, SAS, Clinical Study Design, SAS Programming
Education
Western Michigan University 1998 — 2002
PhD, Statistics, 4.0
Universitatea din Bucuresti
BS, Mathematics
TBC Corporation 2008 - December 2011
Tire Kingdom March 2008 - February 2010
Driftwood Hospitality Management, LLC August 2006 - March 2008
Driftwood Hospitality Management 1997 - 2005
i3 Statprobe 1995 - 2005
Skills
JD Edwards, AS 400, Monarch, Account Reconciliation, Credit Card Analytics, Expense Reports, Performance Dashboards, Microsoft Office 2007, Process Excellence, Process Improvement, Business Process..., Monthly Close Process, Accruals, Project Management, Project Coordination, Project Planning, Accountability, Business Intelligence, Financial Audits, Customer Service, Computer Proficiency, Acquisition Integration, Data Analysis, Data Management, Business Process Mapping, Visionary Thinking, Innovation, IBM iSeries, Income Statement
Education
Colorado Technical University 2006 — 2008
Bachelor's, Business Administration
Colorado Technical University 2006 — 2008
BSBA, Business Management; Business Administration; Project Management
University of Phoenix
Masters of Science, Information Technology
Chiltern July 2015 - Present
Theorem Clinical Research September 2013 - July 2015
inVentiv Health Clinical April 2013 - September 2013
Clinical Solutions Group (CSG, Inc.) May 2012 - March 2013
PPD June 2011 - May 2012
PPD December 2009 - June 2011
i3 StatProbe February 2009 - March 2010
PPD Inc. June 2005 - February 2009
Parke-Davis / Pfizer 2000 - 2005
Skills
SDTM, Oracle Clinical, EDC, Clinical Data Management, CRO, Clinical Trials, Inform, GCP, 21 CFR Part 11, Biostatistics, SAS programming, Data Management, Pharmaceutical Industry, Validation, SAS, Clinical Research, CTMS, MedDRA, Therapeutic Areas, Regulatory Affairs, SAS Programming, Clinical Development, Oncology, Statistical Programming
Education
Grand Valley State University 1992 — 1994
BS, Mathematics
ICON March 2008 - September 2009
i3 Statprobe September 2006 - March 2008
Austin Logistics Inc. 2003 - 2006
Education
The University of Texas at San Antonio 1999 — 2001
MS, Mathematics/Statistics
The University of Texas at Austin 1989 — 1991
Heart Metabolics LTD June 2015 - Present
Akebia Therapeutics May 2008 - June 2015
Quintiles International August 2007 - May 2008
Pfizer June 2005 - June 2007
PGRD 2005 - 2005
Pfizer/Parke-Davis 1999 - 2004
i3 STATPROBE September 1996 - November 1999
Statprobe, Inc. 1996 - 1999
Mallinckrodt Medical 1985 - 1996
Skills
Pharmaceutical Industry, Clinical Development, CTMS, CRO, Biotechnology, Clinical Trials, Project Planning, Business Development, Timelines, Drug Discovery, Project Management, Contract Management, Logistics Management, New Business Development, GCP, Drug Development, Oncology, Life Sciences
Education
Eastern Michigan University
Master's degree, Biology, General
University of Missouri-Saint Louis
Bachelor of Science (B.S.), Biology/Biological Sciences, General
inVentiv Health Clinical August 2013 - June 2015
Riverview Writing, Inc. July 2007 - August 2013
Contract with JPG and Associates 2012 - July 2013
Anoka-Ramsey Community College October 2010 - April 2012
i3 Statprobe February 2008 - June 2010
Boston Scientific 2007 - 2008
Mayo Clinic August 2006 - June 2007
3M Pharmaceuticals April 2002 - August 2006
Technical Communication Services, Inc December 1998 - January 2002
Medtronic CRDM 1999 - 2001
Skills
Technical Writing, Technical Communication, Technical Documentation, Web Content, Editing, Software Documentation, FrameMaker, Captivate, FDA, Medical Devices, Newsletters, Quality Assurance, Content Development, Training, Publishing, Manuals, Clinical Trials, Content Management, Regulatory Affairs, Medical Writing
Education
University of Minnesota-Twin Cities 1991 — 1993
BS, High Distinction, Scientific and Technical Communication
University of Wisconsin-Stout 2004 — 2006
Master's degree, Training and Development
Normandale Community College
AA Pre, Scientific and Technical Communication
Wayne Community College
Diploma, Practical Nursing
inVentiv Health Clinical May 2014 - Present
inVentiv Health Clinical June 2011 - Present
i3 Statprobe April 2010 - June 2011
Lilly August 2009 - September 2010
I3 Statprobe 2010 - 2010
Eli Lilly January 2007 - August 2009
Duke University Medical Center January 2002 - February 2007
Skills
Biostatistics, Clinical Trials, Oncology, SAS, CRO, CDISC, SAS programming, Clinical Research, Pharmaceutical Industry, SAS Programming
Education
Colorado State University 1999 — 2002
Masters of Science, Statistics
Colorado State University 1994 — 1998
Bachelors of Science, Psychology (minor statistics)
UnitedHealth Group November 2001 - Present
i3 2005 - 2005
i3 Statprobe December 2001 - January 2004
SE Johnson / Stone Co 1998 - 2001
Wade Trim July 1993 - October 1997
Skills
Windows Server, Virtualization, Citrix, Software Development, Disaster Recovery, Management
Education
The University of Akron 1986 — 1989
computer science
Amgen March 2012 - Present
Micromet July 2011 - March 2012
i3 Statprobe August 2010 - July 2011
i3 Statprobe January 2009 - August 2010
Eli Lilly March 2002 - January 2009
Skills
Medical Writing, Regulatory Submissions, Oncology, Protocol, Biostatistics, Epidemiology, Clinical Trials, FDA, Publications, Pharmaceutical Industry
Education
Indiana University School of Medicine 2006 — 2009
Masters, Epidemiology and Public Health
Butler University
BA, English Literature
Celgene December 2011 - October 2012
Celgene June 2010 - December 2011
Celgene January 2008 - June 2010
Celgene December 2005 - January 2008
Abbott Laboratories 2005 - 2005
i3 Statprobe 2001 - 2005
Education
Stevens Institute of Technology
New Jersey Institute of Technology 2001 — 2003
Master of Science (MS), Statistics
College of Saint Elizabeth 1997 — 2003
BS, Biology
County College of Morris 1994 — 1997
Nursing
City of Ann Arbor August 2005 - Present
i3 Statprobe September 2003 - August 2005
Entertainment Publications Inc 2000 - 2003
Skills
Management, Onboarding, Labor Relations, HRIS, Networking, Full-cycle Recruiting, Direct Recruiting, Coaching, Strategic Thinking, Organizational..., Organizational Change, Corporate Communications, Market Research, Supervisory Skills, Human Resources, Performance Management
Education
Eastern Michigan University 2007 — 2010
MSHROD, Human Resource
Florida Metropolitan University 1994 — 1997
Bachelor's Degree, Business Administration, Human Resources
Leadership A2Y
Orexigen March 2008 - December 2013
Neurocrine Biosciences June 2005 - March 2008
Isis Pharmaceuticals 2004 - 2005
i3 Statprobe 1998 - 2004
Skills
CRO, Pharmaceutical Industry, SAS, Clinical Development, Clinical Trials, Statistical Programming, CDISC, FDA, Biotechnology, Clinical Data Management, SAS programming, EDC, Data Management
Education
Southern Connecticut State University 1996 — 1998
MS, Research, Statistics, Measurement
University of North Carolina at Chapel Hill 1989 — 1993
CPC Research January 2014 - Present
CPC Research September 2013 - January 2014
TOLMAR July 2003 - September 2013
QLT Inc. 2003 - 2006
Atrix Laboratories 2003 - 2005
i3 Statprobe October 1998 - July 2003
Skills
Clinical Trials, Biostatistics, Data Management, Protocol, SAS, Clinical Study Design, Pharmaceutical Industry, Clinical Development, GCP, Oncology, Validation, Regulatory Submissions, Sop, Data Analysis, Statistical Programming, EDC, Statistical Modeling, ICH-GCP, Statistical Consulting, Pharmacokinetics, Dermatology, Biotechnology, CRO, Clinical Data Management, Clinical Research, FDA, Life Sciences, Drug Development
Education
Brigham Young University 1993 — 2000
MS, Statistics
Daiichi Sankyo, Inc. July 2015 - Present
Ambit Biosciences February 2011 - Present
Biogen Idec July 2002 - January 2011
i3 Statprobe 1997 - 2002
Statprobe, Inc. 1997 - 2002
NHRC 1995 - 1997
Skills
Biotechnology, Clinical Study Design, Clinical Development, Drug Development, Clinical Trials, Oncology, Pharmaceutical Industry, Biostatistics, GCP, CRO, CTMS, Clinical Data Management, Lifesciences, Therapeutic Areas, EDC, FDA, Regulatory Submissions, CDISC, Clinical Research
Education
University of California, Berkeley 1987 — 1991
Intercept Pharmaceuticals July 2015 - Present
Intercept Pharmaceuticals December 2014 - July 2015
Self-Employed April 2014 - December 2014
Amylin Pharmaceuticals January 2010 - April 2014
Amylin Pharmaceuticals September 2007 - December 2009
i3 Statprobe August 2006 - September 2007
Synteract, Inc. September 2003 - August 2006
Skills
CDISC, Biostatistics, SAS programming, CRO, Clinical Trials, SAS, R, Oncology, Pharmaceutical Industry, FDA, SDTM, Clinical Research, Statistics, Biotechnology, GCP
Education
San Diego State University-California State University 2006 — 2009
MS, Statistics
San Diego State University-California State University 1998 — 2002
BS, Statistics, Finance Minor
Covidien October 2013 - Present
Covidien, Inc March 2010 - September 2013
Independent Consultant October 2009 - March 2010
i3 Statprobe June 2009 - September 2009
DePuy Orthopaedics May 2007 - June 2009
DePuy Orthopaedics November 2006 - May 2007
DePuy Orthopaedics November 2004 - November 2006
Cleveland Clinic September 1993 - November 2004
Skills
Clinical Data Management, Medical Devices, Clinical Trials, Oncology, Hematology, EDC, FDA, Pharmaceutical Industry, Lifesciences, Clinical Development, Data Management, Hospitals, Regulatory Affairs, Clinical Research, Validation, Healthcare, CRO, Biotechnology, Cardiology, SAS, CTMS, Regulatory Submissions, ISO 13485, GCP, 21 CFR Part 11
Education
Cleveland State University 1989 — 1995
BS, Chemistry
Abbvie January 2015 - Present
Veristat, Inc. February 2009 - Present
Eliassen Group - Pfizer May 2010 - August 2011
i3 Statprobe February 2008 - August 2009
Clinsys Clinical Research October 2008 - January 2009
Skills
CDISC, Clinical Trials, Pharmaceutical Industry, SAS Programming, SAS, Oncology, Clinical Data Management, CRO, Statistical Programming, FDA, SDTM
Education
Bowling Green State University 1992 — 1996
Agility Clinical, Inc. November 2013 - Present
Synteract, Inc. July 2011 - November 2013
Synteract, Inc. January 2005 - June 2011
Synteract, Inc. January 2003 - January 2005
Synteract, Inc. January 2002 - January 2003
Synteract, Inc. January 2001 - January 2002
i3 Statprobe August 1998 - January 2001
University of California, San Diego October 1996 - August 1998
Skills
Oracle Clinical, Inform, Database Design, EDC, Clinical Trials, Drug Development, CRF design, Clinical Data Management, Data Management, Oncology, Sop, Therapeutic Areas, SAS, Clinical Research, Medidata, SOP, CRO, Analytics
Education
University of California, San Diego 1998 — 1999
Professional, Clinical Research Design and Management
Grossmont College 1997 — 1998
License, Pharmacy Technician
University of California, San Diego 1994 — 1998
BS, Biochemistry/Chemistry
Southwestern College 1992 — 1994
AA, General Studies
Montgomery High School 1989 — 1992
Millennium Pharmaceuticals January 2013 - Present
Repligen Corporation and Repligen Europe Limited June 2011 - August 2012
Morris International LLC July 2007 - June 2011
University of Michigan 2002 - 2005
Esperion Therapeutics 1999 - 2002
i3 Statprobe 1998 - 1999
Parke-Davis Pharmaceutical Research 1995 - 1998
Skills
Contingency Planing..., Writing (regulatory,..., Strategic Planning, Business Strategy, Excellent Communication..., Microsoft Office, Mac or PC, Clinical Research, Global Drug Development, EU Centralised..., PIP, RMP, DDPS, Orphan Application, PIL, SmPC, Biostatistics, Published Author
Education
University of Michigan 1997 — 1999
MS, Clinical Research Design and Statistical Analysis
Northeastern University 1978 — 1986
BSN, Nursing
Illumina, Inc May 2014 - October 2014
Dendreon Corporation May 2013 - April 2014
Writing Assistance, Inc 2009 - 2014
Your Encore, Inc. February 2005 - 2014
Merz Pharmaceuticals, LLC January 2011 - May 2012
Falcon Consulting Group, LLC August 2008 - May 2009
i3 Statprobe January 2005 - June 2008
Allergan, LLC July 2003 - December 2003
La Jolla Pharmaceutical Company July 2001 - January 2003
NAMSA January 1999 - August 2000
Skills
Medical Writing, Clinical Development, Regulatory Submissions, Medical Affairs, Pharmacology, Pharmaceutical Industry, Oncology, GCP, Clinical Research, Pharmaceuticals, Medical Devices, Journal Manuscripts,..., Grant Applications,..., University Teaching, Medical Education, Preclinical Research, Established..., Protocol, Immunology, Clinical Trials, Neurology, SOP, CRO, Biopharmaceuticals, Vaccines, Dermatology, Biotechnology, Therapeutic Areas
Education
University of California, Santa Barbara
NIH postdoctoral research fellowship (NRSA National Institute on Aging)
University of Oregon; University of California Santa Barbara
PhD
University of California, Santa Barbara
Masters Degree
TESARO, Inc. May 2015 - Present
Biogen Idec August 2013 - April 2015
Biogen Idec October 2011 - August 2013
i3 Statprobe October 2010 - October 2011
Eli Lilly and Company June 2009 - October 2010
Natural Standard (Integrative Medicine Website) October 2008 - June 2009
Hollis Eden Pharmaceuticals May 2008 - June 2009
University of California January 2006 - June 2009
Harvard Medical School November 2004 - December 2005
Niigata University Graduate School of Medical and Dental Sciences October 2000 - October 2004
Skills
Clinical Trials, Clinical Research, Drug Discovery, Assay Development, Publications, Neuroscience, Oncology, Infectious Diseases, Lifesciences, Biotechnology, Pharmaceutical Industry, Medical Writing, Molecular Biology, Biochemistry, Pharmacology, Protein Chemistry, Immunohistochemistry
Education
University of California, San Diego 2007 — 2010
certificate, regulatory affairs for biomedical drug
Niigata University of Medical and Dental Sciences 2000 — 2004
PhD, Pathology
Universidade Estadual Paulista Júlio de Mesquita Filho 1995 — 1998
DDS, Dentistry
inVentiv Health Clinical November 2013 - Present
inVentiv Health Clinical March 2010 - Present
i3 Statprobe 2008 - March 2010
PPD 2006 - 2008
Chiltern 2002 - 2006
PPD 1998 - 2002
Skills
Clinical Data Management, Clinical Data, Oracle Clinical, EDC, CRF design, CRO, Medidata, ICH-GCP, GCP
Education
Mclennan Community College 1989 — 1991
AAS, Management/Fasion Merchandising
Onyx Pharmaceuticals November 2014 - Present
Genentech January 2005 - October 2014
i3 Statprobe June 1998 - December 2004
STATPROBE Inc 1998 - 2004
Clintrials Research, Inc March 1988 - June 1998
Skills
Clinical Development, CRO, Oncology, EDC, Therapeutic Areas, Clinical Trials, Biotechnology, Clinical Data Management, Pharmaceutical Industry, GCP, 21 CFR Part 11, FDA, Pharmacovigilance, Sop, Drug Development, Biopharmaceuticals, Lifesciences, Regulatory Submissions, Validation, Regulatory Affairs, IND, SOP, Life Sciences
Education
Eastern Kentucky University 1985 — 1988
BS, Math/Stats
High School
Regeneron Pharmaceuticals, Inc. April 2014 - Present
Regeneron Pharmaceuticals April 2013 - Present
ICON plc January 2012 - April 2013
i3 Statprobe August 2010 - January 2012
Eisai Medical Research February 2009 - August 2010
sanofi-aventis November 2005 - February 2009
Spectra February 2005 - November 2005
Clinstitute Inc. May 2001 - December 2004
Skills
SAS programming, SAS, CDISC, EDC
Education
University of Phoenix 2009 — 2013
DM/IST, Doctorate of Management in Organizational Leadership/Information Systems and Technology
Bharathiar University 1999 — 2001
M.Sc, Computer Science
Bharathiar University 1996 — 1999
B.Sc, Computer Science
inVentiv Health Clinical July 2015 - Present
inVentiv Health clinical February 2010 - July 2015
i3 Statprobe March 2002 - April 2010
University of Michigan January 2000 - March 2002
POH Regional Medical Center August 1991 - March 1999
Skills
EDC, Clinical Data Management, GCP, Clinical Trials, SAS, CTMS, CRO, GMP, Quality Control, Oracle Clinical, Medidata, ICH-GCP, CRF design, Inform, Oncology, Clinical Development, CDISC, Data Management, 21 CFR Part 11, Sop
Education
Walsh College 1990 — 1992
BBA, Business Admin, Marketing
Oakland Community College 1987 — 1989
Accounting, Business
Waterford Kettering 1984 — 1987
PPD May 2014 - Present
PPD April 2011 - April 2014
i3 statprobe July 2009 - April 2011
PPD August 2007 - June 2009
PPD June 2006 - July 2007
Texas State University August 2004 - May 2006
Skills
SAS programming, Clinical Trials, CRO, CDISC, SAS, Biostatistics, Statistical Programming, 21 CFR Part 11, Pharmaceutical Industry, Oncology, ICH-GCP, SQL, Data Management, EDC, GCP, Oracle Clinical, SAS Programming
Education
Texas State University 2004 — 2006
MS, Computer Science
University of Madras 2001 — 2004
BE, Computer Science
inVentiv Health June 2013 - Present
PharmaNet/i3 March 2008 - June 2013
i3 Statprobe 2006 - 2008
i3 Statprobe 2002 - 2006
Skills
Clinical Data Management, EDC, CRO, Oracle Clinical, Data Management, Clinical Trials, GCP, Data Validation, Validation, Clinical Research, SAS, Pharmaceutical Industry, Sop, Inform, Oncology, Software Documentation, CRF design, FDA, Medidata, 21 CFR Part 11
Education
Sullivan University 2001 — 2001
none, Computer programmng
Kankakee Community College 1994 — 1996
Accounting
Quintiles March 2015 - Present
OptumInsight 2007 - March 2015
i3 Statprobe September 2000 - December 2007
Skills
CRO, Clinical Research, Clinical Trials, EDC, Project Management, GCP, CTMS
Education
Georgetown College 1984 — 1987
B.S., Environmental Science
self-employed September 2008 - Present
INC Research (formerly Kendle International) 2011 - August 2014
i3 Statprobe August 2005 - August 2008
The Write Solution January 2000 - December 2003
Skills
Clinical Development, FDA, Medical Writing, Pharmaceutical Industry, Neurology, Oncology, Clinical Trials, Dermatology, Infectious Diseases, Immunology, Gastroenterology, Endocrinology, CRO, GCP, Clinical Research, Biotechnology, Regulatory Submissions, Life Sciences, ICH-GCP, Drug Development, CTMS, Therapeutic Areas, Regulatory Affairs, Direct Patient Care, Management
Education
Duke University School of Medicine
Physician Assistant, medicine
The University of Connecticut School of Medicine
M.Sc. (incomplete), Community Medicine
Bucknell University
Bachelor's degree, Psychology (experimental)
Nationstar Mortgage November 2012 - Present
Shepard International September 1999 - Present
ClinForce, LLC January 2011 - March 2012
i3 Statprobe November 2008 - December 2010
Eli Lilly August 2007 - January 2010
Theoris March 2006 - August 2007
WVPA November 2004 - December 2005
Indiana University Kokomo February 2002 - November 2004
Conseco September 1997 - March 2001
Financialware, Inc May 1996 - September 1997
Skills
Database Design, Project Management, Data Analysis, Software Documentation, Business Analysis, Visio, Data Management, SQL, Databases, Oracle, Business Intelligence, Data Warehousing, Process Improvement, Integration, Requirements Analysis, Microsoft SQL Server, Software Development, Unix, Business Process
Education
Ball State University 1986 — 1991
BS, Computer Science
Company Confidential 2008 - Present
INC Research 2007 - 2008
Company Confidential 2006 - 2007
i3 Research 2005 - 2006
i3 Statprobe 2004 - 2005
John Wayne Cancer Institute 2003 - 2004
Beckman Coulter 2002 - 2004
Ribapharm Inc. 2002 - 2003
Horizon Medical 2000 - 2002
Watson Pharmaceuticals 1999 - 2000
Education
California State University-Dominguez Hills
Master of Science (MS), Quality Assurance
California State University-Fullerton
Bachelor of Science (BS), Biochemistry
inVentiv Health Clinical October 2012 - Present
PharmaNet/i3 (inVentiv Health) September 2010 - September 2012
i3 Statprobe May 2009 - November 2010
MMS Holdings September 2007 - May 2009
University of Michigan January 2006 - October 2007
Skills
Oncology, Medical Writing, Clinical Trials, CRO, Neuroscience, Pharmaceutical Industry, Regulatory Submissions, Publication Planning, Lifesciences, GCP, Clinical Research, Therapeutic Areas, Regulatory Affairs, IND, Drug Development, Protocol, Neurology, ICH-GCP, Clinical Study Design, Life Sciences
Education
Western Michigan University 2000 — 2006
PhD, Neurobiology
Grand Valley State University 1996 — 2000
BS, Biology
Bedford Highschool
inVentiv Health Clinical April 2001 - November 2013
i3 Statprobe January 2008 - September 2008
i3 Statprobe April 2001 - December 2007
Skills
Clinical Data Management, EDC, Clinical Data, CRO, Clinical Trials, Inform, Oracle Clinical, SAS, Clinical Research, GCP
Education
University of Kentucky 1996 — 1997
University of Louisville 1994 — 1995
Communications
Bryan Station High School 1990 — 1994
inVentiv Health Clinical January 2013 - Present
INC Research November 2012 - January 2013
PharmaNet/i3 October 2011 - November 2012
i3 Statprobe July 2010 - October 2011
US Census Bureau March 2010 - June 2010
Jovial LLC June 2006 - January 2009
PPD 2001 - 2005
Covance 1994 - 1997
Skills
Inform, Clinical Data Management, EDC, Oracle Clinical, Clinical Trials, GCP, CRO
Education
St. Edward's University 1998 — 2000
MBA, Business Administration
inVentiv Health September 2010 - Present
United BioSource Corp. November 2008 - September 2010
i3 Statprobe January 2005 - September 2008
i3 Statprobe January 2004 - January 2005
STATPROBE Inc 1998 - January 2004
Skills
SAS Programming, MS Office Suite, HTML, Data Analysis, Clinical Trials, GCP, SAS, Pharmaceutical Industry, Analysis, CDISC, Oncology, Clinical Data Management, Software Documentation, Programming, Statistics, SAS programming, Microsoft Office, CRO, Biotechnology, Clinical Development, EDC, Data Management, Pharmacovigilance, Therapeutic Areas, 21 CFR Part 11, FDA, SDTM
Education
Eastern Michigan University
B.A.S, Technical Writing, English
Washtenaw Community College
A.A.S, Technical Writing
Clinical Research July 2011 - Present
ICON Clinical Research July 2009 - July 2011
Prologue Research November 2007 - June 2009
i3 Statprobe 2002 - 2006
MetroMed / Lexis Pharmaceuticals 1985 - 1987
Skills
Regulatory Affairs, Clinical Operations, CRO, Clinical Development, CTMS, Clinical Research, GCP, EDC, Clinical Trials, Lifesciences, Project Management, Product Development, Clinical Data Management, Oncology, Operations Management, Pharmacokinetics, Drug Development, State Formularies, Regulatory Submissions, Life Sciences
Education
Duke University 1979 — 1981
Radiology
Loyola University Chicago 1975 — 1979
B.S., Biology
Lincare Holdings, Inc November 2010 - Present
Kinney Drugs August 2009 - Present
Cortland Regional Medical Center November 2009 - November 2010
PAREXEL June 2008 - October 2008
i3 Statprobe October 2006 - April 2008
i3 Research October 2004 - October 2006
PPD April 2004 - September 2004
PAREXEL April 2001 - February 2004
Duke Clinical Research Institute October 1997 - March 2001
Education
The Center for New Careers at OCM BOCES 2009 — 2009
Pharmacy Technician Certification
North Carolina Wesleyan College 2002 — 2005
B.S., Business Management
SUNY Canton College of Technology 1988 — 1991
A.A, Restaurant Management
INC Research February 2013 - Present
PAREXEL February 2012 - January 2013
Ockham Development Group (Acquired by Chiltern International 2014) June 2010 - January 2012
i3 Statprobe November 2005 - June 2010
Quintiles 2004 - 2005
Skills
Oracle Clinical, Clinical Data Management, Medidata, EDC, CRO, GCP, Data Validation, Data Management, Clinical Trials, ICH-GCP, CRF design, CDISC, CTMS
Education
North Carolina State University 1995 — 1998
BS, Biochemistry/Microbiology
PharmaNet/i3 April 1998 - Present
i3 Statprobe April 1998 - February 2008
Difco Laboratories, Inc. 1986 - 1998
Education
Eastern Michigan University 1981 — 1983
MBA, Operations Research
i3 Statprobe OwnerMetal TecJanuary 1992 - January 1995
Blue Cross Blue Shield Medicare August 1971 - September 1991
Skills
Clinical Data Management, CRO, Sop, ICH-GCP, Clinical Trials, Data Management, Therapeutic Areas, EDC, Clinical Development, Oncology, Oracle Clinical, CTMS, Clinical Research, Pharmaceutical Industry, GCP, Regulatory Submissions, SAS, Protocol, Biostatistics, Inform, Biotechnology, 21 CFR Part 11, Infectious Diseases, Clinical Study Design, Pharmacovigilance, Clinical Monitoring, Medical Writing
Education
Georgetown College 1967 — 1970
Aeroflex/Inmet HR ManagerAerolfex/InmetFebruary 2006 - Present
DLZ Corporation 2002 - 2005
The NEWSGroup - Midwest 2000 - 2002
Washtenaw Engineering Company 1997 - 2000
i3 Statprobe 1996 - 1997
The Newman Group 1985 - 1996
Education
Eastern Michigan University
MS, Org Development/HR Management
PPD January 2011 - Present
i3 Statprobe August 2010 - January 2011
PPD April 2004 - August 2010
PPD, Inc. August 1999 - April 2004
PPD 1996 - 1998
Skills
Data Management, Validation, Protocol, Oracle Clinical, GCP, EDC, Databases, Database Design, Clinical Trials, Clinical Research, Clinical Data Management, CTMS, CRO
Education
The University of Texas at Austin 1992 — 1996
B.S., Biology
PPD February 2015 - Present
Pentara Corporation October 2014 - February 2015
PAREXEL July 2013 - October 2014
UCB Biosciences, Inc. May 2012 - July 2013
Genzyme March 2011 - May 2012
PAREXEL September 2010 - March 2011
Ockham February 2010 - August 2010
DataCeutics September 2009 - January 2010
i3 Statprobe July 2008 - September 2009
Myriad Genetics April 2005 - July 2008
Skills
CDISC, SAS, Validation, Clinical Trials, Statistics, Programming, Biostatistics, Analysis, Statistical Programming, Data Management, Clinical Research, CRO, Pharmaceuticals, Clinical Data Management, Research, Problem Solving, Pharmaceutical Industry, 21 CFR Part 11, SAS programming, Data Analysis, SAS Programming, Oracle Clinical, GCP, SAS Base
Education
Utah State University 1996 — 1998
Bachelors, Statistics
Brigham Young University 1987 — 1995
Bachelors, Psychology, Statistics
Cincinnati Children's Hospital Medical Center February 2012 - Present
i3 Statprobe January 2011 - February 2012
i3 Statprobe January 2009 - December 2010
i3 Statprobe April 2007 - January 2009
Kendle International March 2006 - April 2007
Kendle 2001 - 2007
Kendle International March 2002 - March 2006
Kendle International June 2001 - March 2002
Skills
SAS, Clinical Trials, Programming, Validation, Analysis, CDISC, People Management, Statistical Programming, Management, Biostatistics, Regulatory Submissions, Scientific Programming, Protocol, CRO, EDC, Pharmaceutical Industry, GCP, Data Management, Clinical Data Management
Education
University of Cincinnati 2003 — 2010
MS, Biostatistics
Agnes Scott College 1995 — 1999
BA, Bio-Psychology
contractor August 2014 - Present
inVentiv Health Clinical May 2010 - August 2014
i3 statprobe February 2008 - May 2010
Skills
Strategy, Clinical Trials, Biotechnology
Education
Rutgers University-New Brunswick 1995 — 2000
PhD, neuroscience
INC Research (acquired Kendle Jul-2011) September 2008 - Present
i3 Statprobe October 2006 - September 2008
MGI Pharma May 2001 - October 2006
MedFocus May 2000 - May 2001
Physicians' Education Resource January 1999 - January 2000
University of North Carolina January 1998 - January 1999
CAROLINAS MEDICAL CENTER January 1992 - January 1999
Skills
Orthopedic, Medical Writing, Oncology, Clinical Trials, Clinical Study Design, Therapeutic Areas, Protocol, Biostatistics, Abstracts, Infectious Diseases, Neurology, Diabetes, Pharmaceutical Industry, Clinical Development, Clinical Research, CRO, Biotechnology, Lifesciences, Regulatory Submissions, Hematology
Education
University of Louisville School of Medicine 1986 — 1991
PhD, Pharmacology
University of Kentucky 1981 — 1985
BS, Chemistry
inVentiv Health Clinical May 2012 - Present
i3 Statprobe May 2007 - May 2012
i3 Statprobe June 2009 - December 2010
INC Research 2003 - 2007
Skills
Clinical Trials, Clinical Data Management, CRO, EDC, Clinical Development, Oncology, GCP, Pharmaceutical Industry, Oracle Clinical, Inform, Data Management, Clinical Research, ICH-GCP, OC RDC, CRF design, CTMS, Medical Writing, Biotechnology, Sop, Infectious Diseases
Education
University of Cincinnati 2001 — 2002
MBA
University of Cincinnati 1996 — 2001
BS, Biological Sciences
PharmaNet/i3 May 2012 - Present
Delta, a Randstad Company July 2011 - May 2012
i3 Statprobe 2009 - July 2011
Targanta Therapeutics 2006 - 2009
Eli Lilly and Company 2000 - 2006
Covance Laboratories 1998 - 2000
Skills
Project Management, Medical Writing, Management, Pharmaceutical Industry, Clinical Development, Oncology, Regulatory Submissions, CRO, GCP, FDA, Regulatory Affairs, Biotechnology, Infectious Diseases
Education
Ball State University 2003 — 2006
Master of Business Administration, Project Management/Business
Purdue University 1994 — 1998
Bachelor of Arts, English Literature
Platinum Financial Partners, LLC May 2008 - Present
i3 Statprobe 2003 - 2006
ASC System Consultants 2001 - 2003
Adelphia Business Solutions 1998 - 2001
RAM Mobile Data 1988 - 1998
Ayerst Laboratories 1982 - 1988
Education
Queens College 1977 — 1980
BA, Life Science/Biology
Eli Lilly and Company February 2012 - Present
i3 Statprobe February 2010 - July 2012
i3 Statprobe November 2008 - January 2012
Eli Lilly February 1995 - November 2008
Education
Indiana University Bloomington
i3 Statprobe April 2000 - Present
Duke Clinical Research Institute 1995 - 1999
Chathamborough Research Group 1990 - 1994
Travelers Insurance Company 1988 - 1989
Health Force 1987 - 1988
Our Lady of the Lake Regional Medical Center 1978 - 1987
Education
University of Delaware 1973 — 1977
BSN, RN, Nursing
PAREXEL September 2012 - Present
PharmaNet/i3 June 2011 - September 2012
i3 Statprobe December 2009 - June 2011
Skills
Clinical Development, Clinical Trials, Pharmaceutical Industry, CRO, CTMS, Therapeutic Areas, Strategy, EDC, GCP, Data Management, SAS programming, Strategic Partnerships, Drug Development, Leadership, Biostatistics, Oncology, Business Development, Regulatory Submissions
Education
University of Cincinnati 1991 — 1993
MS, Statistics
Thomas More College 1987 — 1991
Bachelor's degree, Mathematics
University of Kentucky March 2011 - Present
University of Kentucky August 2010 - March 2011
i3 Statprobe June 2006 - April 2008
Morehead State University August 1998 - May 2002
Education
Morehead State University
MS, Physiological Psychology
Morehead State University
BA, Psychology and Intergrated Sciences
AstraZeneca June 2014 - Present
MedImmune April 2011 - June 2014
i3 Statprobe November 2008 - May 2011
i3 Statprobe July 2006 - November 2008
University of Michigan 2004 - 2005
Pfizer 1999 - 2003
Skills
Medical Writing, Pharmaceutical Industry, Publication Planning, Biotechnology, Oncology, Clinical Development, GCP, Publication Development, Project Management, Clinical Trials, Biologics, Respiratory Disease, Scientific..., Pharmacology, CRO, Neuroscience, Diabetes, Lifesciences, Team Management, Team Leadership, Protocol
Education
The University of Kansas 1980 — 1984
MS, PhD, Pharmacology and Toxicology
University of Missouri-Kansas City 1974 — 1977
BS, Biology
PAREXEL May 2013 - Present
inVentiv Health December 2009 - May 2013
i3 Statprobe June 2007 - November 2009
Skills
Biostatistics, Medical Writing, Clinical Study Design, Clinical Research, Statistics, Immunology, Protocol, Data Management, Clinical Trials, CRO, Clinical Development, GCP, Clinical Data Management, EDC, ICH-GCP, Oncology
Education
The Ohio State University 2002 — 2004
Master, Applied Statistics
Zhengzhou University 1989 — 1994
M.D., Medicine
i3 Statprobe 2008 - 2010
Eli Lilly, US Corporate Center, Indianapolis, Indiana 2007 - 2008
Eli Lilly and Company 2001 - 2007
Volt Technical Resources 2000 - 2001
Gradkell Systems Inc 1997 - 2000
AVANTEC 1996 - 1997
Indiana State Department of Health 1985 - 1991
Skills
Clinical Data Management, Clinical Trials, SAS, EDC, Data Management, Sop, Pharmaceutical Industry, Quality Assurance, Requirements Gathering, CRO, Databases
Education
Kentucky State University
BS, Sociology/Biology
The University of Texas Health Science Center at Houston
MPH, Public Health
i3 Statprobe July 2010 - February 2012
Eli Lilly and Company 2012 - 2012
Eli Lilly and Company June 2002 - July 2010
Riley Children's Hospital 1997 - 1999
Skills
Clinical Trials, Data Management, Oncology, Clinical Data Management, EDC, CRO, Pharmaceutical Industry, Clinical Development, Clinical Research, GCP, Drug Development
Education
Indiana University Bloomington
BSN, Nursing
Rodan + Fields Dermatologists June 2012 - Present
Sanofi March 2010 - Present
sanofi-aventis April 2004 - March 2010
Sanofi-Synthelabo December 2001 - April 2004
Cell Therapeutics, Inc. December 2000 - November 2001
I3 Statprobe June 1998 - December 2000
Skills
Biotechnology, Clinical Research, Drug Development, Oracle Clinical, Clinical Trials, Clinical Data Management, SAS, CRO, Oncology, Clinical Development, Sop, CTMS, EDC, Clinical Operations, Databases, Project Management, Therapeutic Areas, Data Management, Protocol
Education
University of Phoenix 1999 — 2001
MBA, Business Administration
University of Michigan 1994 — 1997
BS, Biology
Miami University 1992 — 1994
Novartis April 2013 - Present
Hoffmann-La Roche Inc December 2004 - February 2013
Pfizer December 2000 - December 2004
i3 statprobe 1995 - 2000
Skills
Biostatistical..., SAS Certified Base..., Clinical Data Management, ADAM, CDISC, 21 CFR Part 11, Clinical Trials, SAS 9 Certification, Clinical Development, Statistical Programming, GCP
Education
Biola University 2005 — 2011
Master of Arts (MA)
Eastern Michigan University 1992 — 1997
B. Sc, Computer Programming
Eastern Michigan University
Master’s Degree, Information Systems
inVentiv Health Clinical 2012 - Present
Dell January 2011 - April 2012
i3 Statprobe April 2006 - December 2010
Skills
SAS, Statistics, Data Analysis, SAS programming, Biostatistics, CRO, Data Management, EDC, Clinical Development, Clinical Trials, GCP, CDISC, Clinical Data Management, Statistical Programming, CTMS
Education
Texas State University 1996 — 1999
M.A.G., Geography
The University of Texas at Austin 1989 — 1992
M.S.Stat, Statistics
Trinity University 1985 — 1989
B.S., Mathematics
i3 Statprobe December 2008 - Present
Eli Lilly and Company September 2001 - November 2008
Roudebush Veterans Administration Hospital May 2000 - September 2001
Children's Bureau of Indianapolis January 2000 - May 2000
Skills
Therapeutic Areas, Medical Writing, Clinical Trials, Clinical Research, Literature, IND
Education
Indiana University-Purdue University at Indianapolis 1997 — 2000
MS
Indiana University Bloomington 1991 — 1995
BA
PAREXEL 2014 - Present
Amylin Pharmaceuticals 2012 - 2014
Promedica International 2010 - 2011
i3 Statprobe 2004 - 2009
PAREXEL 2001 - 2004
Isis Pharmaceuticals 1998 - 2001
Education
St. John's College (MD)
MA, Liberal Arts
REGISTRAT MAPI March 2012 - Present
i3 Statprobe June 2007 - May 2011
Pacific Pulmonary Services February 2009 - April 2009
Education
Bluegrass Community and Technical College 2004 — 2006
Mercer County High School 2000 — 2004
General Diploma
inVentiv Health Clinical 2007 - Present
i3 statprobe 2007 - 2008
Johnson & Johnson 2005 - 2007
Sanofi 2004 - 2005
Aventis Pharmaceuticals 2000 - 2004
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Medical Writing, Medicine, Data Analysis, Analysis, Healthcare
Education
Rutgers, The State University of New Jersey-New Brunswick 1995 — 2000
Doctor of Philosophy (Ph.D.), Neurobiology and Neurosciences
Georgian Court College 1972 — 1975
Bachelor of Science (BS), Biochemistry and Molecular Biology