DataCeutics Company
Industry: Company
DescriptionFounded: 1993
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DataCeutics Employees
DataCeutics September 2014 - Present
PAREXEL March 2012 - July 2014
Quintiles July 2011 - February 2012
Premier Research Group June 2007 - July 2011
Premier Research Group June 2006 - May 2007
New England Research Institutes October 2005 - March 2006
New England Research Institutes, Inc. (NERI) June 2004 - October 2005
Brandeis University September 2003 - June 2004
Institute for Community Inclusion June 2003 - September 2003
Skills
CDISC, Clinical Data Management, Statistics, Biostatistics, Oracle Clinical, SAS, SDTM, Pharmaceutical Industry, CRO, SAS programming, Statistical Programming, ICH-GCP, 21 CFR Part 11, Clinical Trials, Data Management, Clinical Research, Clinical Development, GCP, Therapeutic Areas, Oncology, Inform, CTMS, Software Documentation, EDC, Databases, Quality Assurance, Sop, Biotechnology, Drug Development, FDA, Protocol, Pharmacovigilance, Validation, Infectious Diseases, CRF design, Regulatory Submissions, SAS Programming, SOP
Education
Brandeis University 2000 — 2004
BA, English
Harvard University 2005 — 2005
Statistics Courses
DataCeutics October 1993 - Present
Education
Boston University 1986 — 1988
MA
Saint Vincent College 1981 — 1985
BS
DataCeutics December 2005 - Present
Value Added Services June 1998 - December 2005
ClinTrials Research October 1996 - June 1998
ClinTrials Research January 1992 - October 1996
Vestal Museum 1980 - August 1984
Skills
Statistics, Clinical Trials, CDISC, Clinical, Programming, Analysis, Validation, Listings, Data Management, Oncology, Clinical Development, Pharmaceuticals, Clinical Research, CRO, SAS, Statistical Programming, Clinical Data Management, SDTM, EDC, Biostatistics
Education
University of Kentucky 1984 — 1992
MA, Cognitive and Developmental Psychology
State University of New York at Binghamton 1980 — 1983
BA, Psychology
Mesoblast September 2013 - Present
Enzon Pharmaceuticals October 2006 - January 2013
Novartis 2006 - 2006
Genzyme 2005 - 2005
DataCeutics 2000 - 2005
Aventis 2003 - 2004
DZS Software Solutions, Inc. January 2000 - September 2000
Data Analysis Systems April 1997 - December 1999
Citicorp 1993 - 1996
American Express 1990 - 1993
Skills
Biostatistics, Clinical Trials, Oncology, SAS, Statistical Programming, Drug Development, Data Management, Regulatory Submissions, Validation, FDA, SAS programming, Survival Analysis, R, Medical Devices, Logistic Regression, SAS/SQL, RECIST( v1.1), PASS (Sample size..., CDISC/SDTM/ADAM, Monte Carlo Simulation
Education
New York University - Leonard N. Stern School of Business 1988 — 1989
MS, Statistics
Queens College 1983 — 1987
B.A., Applied Mathematics
YMCA of Greater Brandywine June 2015 - August 2015
DataCeutics May 2014 - August 2014
All Star Baseball Academy May 2013 - October 2013
Education
James Madison University 2014 — 2018
Bachelor’s Degree, Justice Studies
DataCeutics 2015 - Present
AstraZeneca 2014 - 2015
AstraZeneca 2013 - 2014
AstraZeneca 2007 - 2013
AstraZeneca 2004 - 2007
Skills
Data Analysis, Data Management, SAS Programming, Statistics, Clinical Research, Leadership, Management, Data Warehousing, Training, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint
Education
Seton Hall University
Master’s Degree, Counseling Psychology
University of Utah
Master’s Degree, Social Psychology w/concentration in Applied Statistics
DataCeutics March 2015 - Present
TalentMine May 2013 - March 2015
ReSearch Pharmaceutical Services January 2012 - May 2013
DataCeutics July 2003 - January 2012
NDCHealth 2002 - 2003
Genomics Collaborative 2001 - 2002
Judge Technical Services 1998 - 2001
Trilogy Consulting 1990 - 1998
Accountline, Inc 1987 - 1990
Skills
SAS, Data Management, Clinical Trials, Lifesciences, Biotechnology, CDISC, SAS programming, Clinical Research, Statistics
Education
University of Pennsylvania 1982 — 1984
MA course work, Regional Science
University of Pennsylvania 1974 — 1978
BA, Reional Science
Pfizer 2011 - Present
Pfizer 2009 - 2011
Wyeth Pharmaceuticals 2005 - 2009
Oracle July 2001 - December 2004
DataCeutics January 1998 - May 2001
Education
University of Scranton 1991 — 1995
BS, Biochemistry, English
Bristol-Myers Squibb September 2004 - Present
CSSC January 2004 - September 2004
DataCeutics January 2003 - January 2004
Skills
Validation, Computer System..., 21 CFR Part 11, FDA, GxP, Quality Assurance, Cross-functional Team..., SDLC, Bio Pharmaceutical, Change Control, Regulatory Affairs, Regulatory Submissions, GAMP, Quality System, CAPA, Mobile technology, V&V, Biotechnology, Software Documentation, Clinical Trials, Lifesciences, GCP, Medical Devices, LIMS, Cloud deployments, ITIL, Inspections and Audits, Agile & Waterfall..., Healthcare, Pharmaceutical Industry, SOP, GMP, GLP, Process Improvement, Life Sciences, Pharmaceutics, Vendor Management, CRO, Business Analysis, Regulatory Requirements, Biopharmaceuticals, Business Process..., Document Management, Requirements Analysis, Project Portfolio..., Testing
Education
San Diego State University-California State University 2008 — 2010
MS, Regulatory Affairs
University of San Diego 2007 — 2010
Masters, Regulatory Affairs
Loreto Convent
Presidency College
Masters, English Literature
DataCeutics May 2014 - Present
Spirit Analytics, Inc. September 2009 - February 2015
Chastain Research Group, Inc. January 2007 - September 2009
Genentech January 2002 - October 2006
Chiron Corporation 1999 - 2002
Covance 1998 - 1999
Scotia Pacific Company LLC 1997 - 1998
Skills
SAS Programming, Clinical Trials, Pharmaceutical Industry, Clinical Development, Biotechnology, CRO, Oncology, EDC, ISS, ISE, CTR, Interpersonal..., CDISC, ADAM, SDTM
Education
Humboldt State University 1986 — 1989
Bachelor's Degree, Forest Management/Forest Resources Management
University of Idaho
Master's Degree, Forest Biometrics
DataCeutics March 2010 - Present
inVentiv Clinical Solutions/Wyeth February 2007 - May 2009
Clinforce/Glaxo Smith Kline June 2004 - February 2007
Omnicare Clinical Research June 2002 - June 2004
Skills
Clinical Trials, CDISC, Oncology, SAS, Biostatistics, FDA, CRO, Pharmaceutical Industry, SAS programming, Validation, 21 CFR Part 11, Data Management, SAS Programming, GCP, CTMS, Clinical Development, Biotechnology, Clinical Research, Clinical Data Management
Education
Chubb Institute 2001 — 2002
Web Development and Business Programming
University of Connecticut 1979 — 1981
M.S., Chemistry
Clark University 1974 — 1978
B.A., Chemistry
BioClinica December 2010 - Present
Octagon Research Solutions August 2005 - December 2010
Dataceutics 1999 - 2005
Decision Associates, Inc February 1997 - June 1999
Skills
Validation, Quality Assurance, 21 CFR Part 11, Computer System..., FDA, Pharmaceutical Industry, GxP, Sop, Project Management, Clinical Trials, GMP, Clinical Data Management, Change Control, Regulatory Submissions, CAPA, GCP, Software Documentation, Regulatory Affairs, LIMS
Education
Penn State University 1991 — 1996
Bachelors, Computer Science & Engineering
Penn State University
Bachelor's degree, Computer Science and Engineering
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
DataCeutics September 2000 - Present
Hurley Consulting Associates Ltd. January 1992 - September 2000
Skills
Clinical Trials, Oracle Clinical, Clinical Data Management, Oncology, CRO, Data Management, Clinical Development, Validation, Clinical Research
Education
Fairfield University 1975 — 1979
BS, Marketing
DataCeutics February 2014 - Present
Theorem Clinical Research April 2011 - July 2013
Theorem Clinical Research January 1999 - April 2011
Skills
CDISC, Clinical Trials, EDC, CRO, Clinical Data Management, CTMS, Clinical Development, GCP, Oracle Clinical, Pharmaceutical Industry, ICH-GCP, Oncology, Clinical Research, Biotechnology, Data Management, Therapeutic Areas, SAS, Regulatory Submissions, Clinical Monitoring, SOP, SAS Programming
Education
State University of New York at Albany 1996 — 1998
M.S., Biometry and Statistics
University at Albany, SUNY 1994 — 1996
B.S., Mathematics, Chemistry Minor
Highland High School 1981 — 1985
High School
LifeCell Corporation June 2014 - Present
Novo Nordisk A/S October 2012 - June 2014
Novo Nordisk A/S September 2010 - October 2012
Novartis 2008 - 2010
Schering-Plough Research Institute 2007 - 2008
NPS Pharmaceuticals 2004 - 2007
DataCeutics 2001 - 2004
Base Ten Systems, Inc 1993 - 1999
Skills
21 CFR Part 11, Computer System..., GxP, GAMP, Validation, Quality Assurance, Change Control, Quality Auditing, SDLC, Cross-functional Team..., Drug Discovery, Software Documentation, Quality System, CAPA, GMP, Sop, Pharmaceutical Industry, LIMS, V&V, SOP
Education
Rensselaer Polytechnic Institute
University of Michigan
DataCeutics July 2013 - Present
Experis Manpower Group June 2010 - June 2013
Skills
SAS programming
Education
University of Cincinnati 1991 — 1994
Master of Science (MS), Mathematical Sciences
The Ohio State University 1975 — 1976
Master of Science (MS), Metallurgical Engineering