CDISC Company
Industry: Non-profit
DescriptionThe Clinical Data Interchange Standards Consortium is an open, multidisciplinary, neutral, 501 non-profit standards developing organization that has been working through productive, consensus-based ... Founded: 1997
CDISC List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at CDISC. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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CDISC Employees
Employee
Years
Job
Industry
Haley Barlow Haley Barlow's CDISC Experience May 2014 - August 2014
Job Student at the University of Notre Dame
Industry Research
Experience
University of Notre Dame February 2014 - Present
University of Notre Dame August 2014 - December 2014
CDISC May 2014 - August 2014
The University of Texas at Austin May 2014 - August 2014
Kinney and Associates May 2013 - August 2013
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Teamwork, Social Media, Public Speaking, English, Windows, Event Planning, Time Management, Team Leadership, Social Networking, Editing
Education
University of Notre Dame 2013 — 2017
Bachelor of Science (B.S.), Biology, General, 3.334 (current)
Stephen F. Austin High School 2009 — 2013
High School
University of Notre Dame February 2014 - Present
University of Notre Dame August 2014 - December 2014
CDISC May 2014 - August 2014
The University of Texas at Austin May 2014 - August 2014
Kinney and Associates May 2013 - August 2013
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Teamwork, Social Media, Public Speaking, English, Windows, Event Planning, Time Management, Team Leadership, Social Networking, Editing
Education
University of Notre Dame 2013 — 2017
Bachelor of Science (B.S.), Biology, General, 3.334 (current)
Stephen F. Austin High School 2009 — 2013
High School
Cara Willoughby Cara Willoughby's CDISC Experience 2003 - 2007
Job Principal Scientific Advisor Bringing Design Thinking to the Biopharma Industry
Industry Pharmaceuticals
Experience
Quintiles April 2015 - Present
Quintiles January 2012 - Present
Quintiles June 2011 - December 2011
Eli Lilly and Company June 2007 - May 2011
Eli Lilly and Company 1997 - July 2007
CDISC 2003 - 2007
Eli Lilly and Company July 2002 - June 2003
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Clinical Research, Medical Writing, Protocol, Informatics, CDISC, Cross-functional Team..., Project Management, Clinical Operations, 21 CFR Part 11, Biotechnology, GCP, Content Management, HL7, Regulations, Clinical Data Management
Education
Purdue University 1994 — 1997
MS, Reproductive Physiology, Cryobiology
Miami University 1989 — 1993
BA, Zoology, Psychology
Quintiles April 2015 - Present
Quintiles January 2012 - Present
Quintiles June 2011 - December 2011
Eli Lilly and Company June 2007 - May 2011
Eli Lilly and Company 1997 - July 2007
CDISC 2003 - 2007
Eli Lilly and Company July 2002 - June 2003
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Clinical Research, Medical Writing, Protocol, Informatics, CDISC, Cross-functional Team..., Project Management, Clinical Operations, 21 CFR Part 11, Biotechnology, GCP, Content Management, HL7, Regulations, Clinical Data Management
Education
Purdue University 1994 — 1997
MS, Reproductive Physiology, Cryobiology
Miami University 1989 — 1993
BA, Zoology, Psychology
Kit Howard Kit Howard's CDISC Experience June 2013 - Present
Job Director of Education at CDISC
Industry Medical Devices
Experience
CDISC June 2013 - Present
Michigan State University August 2012 - Present
Kestrel Consultants January 2004 - Present
Pfizer 2000 - 2003
Pfizer Global Research and Development 2000 - 2003
Parke-Davis Pharmaceutical Research 1990 - 2000
Miles 1988 - 1990
Bayer 1988 - 1990
Bio/dynamics 1985 - 1988
Skills
Clinical data standards, Medical Device Data..., Cross-functional..., Clinical Data Governance, Clinical Data Quality, Data Lifecycle Plans, CDISC, CDASH, SDTM, FDA, Clinical Trials, Clinical Data Management, Clinical Development, Training, Regulatory Requirements, Pharmaceutical Industry, EDC, Data Management, Clinical Research, Clinical Data, Drug Development, Diabetes, GCP, Protocol, Cross-functional Team..., Data Standards, Oncology, Neurology, Biotechnology, Medical Devices, CRO, Phase I, CRF design, Sop, CTMS, Pharmaceutics, Biopharmaceuticals, Informatics, Validation, Lifesciences, Education and Training, 21 CFR Part 11, Cardiology, DLP, Clinical Quality..., Cross-functional..., Case Report Forms, Webinars, Data Quality
Education
University of Michigan
MS, Clinical Research Design and Statistical Analysis
Franklin & Marshall College 1980 — 1984
BA, Biology, History & Philosophy of Science
CDISC June 2013 - Present
Michigan State University August 2012 - Present
Kestrel Consultants January 2004 - Present
Pfizer 2000 - 2003
Pfizer Global Research and Development 2000 - 2003
Parke-Davis Pharmaceutical Research 1990 - 2000
Miles 1988 - 1990
Bayer 1988 - 1990
Bio/dynamics 1985 - 1988
Skills
Clinical data standards, Medical Device Data..., Cross-functional..., Clinical Data Governance, Clinical Data Quality, Data Lifecycle Plans, CDISC, CDASH, SDTM, FDA, Clinical Trials, Clinical Data Management, Clinical Development, Training, Regulatory Requirements, Pharmaceutical Industry, EDC, Data Management, Clinical Research, Clinical Data, Drug Development, Diabetes, GCP, Protocol, Cross-functional Team..., Data Standards, Oncology, Neurology, Biotechnology, Medical Devices, CRO, Phase I, CRF design, Sop, CTMS, Pharmaceutics, Biopharmaceuticals, Informatics, Validation, Lifesciences, Education and Training, 21 CFR Part 11, Cardiology, DLP, Clinical Quality..., Cross-functional..., Case Report Forms, Webinars, Data Quality
Education
University of Michigan
MS, Clinical Research Design and Statistical Analysis
Franklin & Marshall College 1980 — 1984
BA, Biology, History & Philosophy of Science
Dana Booth Dana Booth's CDISC Experience Research Analyst 4Oregon Department of EducationSeptember 2012 - November 2012
Job Clinical Trials Data Standards Development Consultant at CDISC
Industry Pharmaceuticals
Experience
CDISC Research Analyst 4Oregon Department of EducationSeptember 2012 - November 2012
Salem-Keizer School District September 2010 - June 2012
Assessment Technology, Inc November 2003 - July 2005
PRO Unlimited May 2000 - August 2003
Southwest Physicians Network August 1999 - February 2000
American Express Corporation September 1997 - August 1999
GSK September 1996 - September 1997
Quintiles September 1995 - September 1996
FHI 360 February 1991 - September 1995
Skills
Technical Writing, Report Writing, Microsoft Word, Analysis, Data Analysis, Lesson Planning, Classroom, Curriculum Design, Classroom Management, Tutoring, Curriculum Development, Elementary Education, Differentiated..., K-12, Educational Leadership, Educational Technology, Teaching, Special Education, Literacy, Instructional Technology, Teacher Training, Adult Education, SAS programming, WordPress, Microsoft Excel
Education
Virginia Polytechnic Institute and State University 1989 — 1990
Master of Science, Statistics
James Madison University 1985 — 1988
Bachelor of Science, Mathematics
George Mason University 1983 — 1985
CDISC Research Analyst 4Oregon Department of EducationSeptember 2012 - November 2012
Salem-Keizer School District September 2010 - June 2012
Assessment Technology, Inc November 2003 - July 2005
PRO Unlimited May 2000 - August 2003
Southwest Physicians Network August 1999 - February 2000
American Express Corporation September 1997 - August 1999
GSK September 1996 - September 1997
Quintiles September 1995 - September 1996
FHI 360 February 1991 - September 1995
Skills
Technical Writing, Report Writing, Microsoft Word, Analysis, Data Analysis, Lesson Planning, Classroom, Curriculum Design, Classroom Management, Tutoring, Curriculum Development, Elementary Education, Differentiated..., K-12, Educational Leadership, Educational Technology, Teaching, Special Education, Literacy, Instructional Technology, Teacher Training, Adult Education, SAS programming, WordPress, Microsoft Excel
Education
Virginia Polytechnic Institute and State University 1989 — 1990
Master of Science, Statistics
James Madison University 1985 — 1988
Bachelor of Science, Mathematics
George Mason University 1983 — 1985
Lex Jansen Lex Jansen's CDISC Experience June 2008 - Present
Job Software Developer, Healthcare and Life Sciences at SAS
Industry Computer Software
Experience
SAS Institute Inc. February 2011 - Present
CDISC June 2008 - Present
lexjansen.com July 2003 - Present
Octagon Research Solutions June 2008 - February 2011
Take Solutions Inc. July 2007 - June 2008
Organon USA Inc. April 2004 - July 2007
NV Organon January 1992 - March 2004
Statistics Netherlands (CBS) September 1990 - December 1991
Skills
SAS, CDISC, CDISC Define-XML, CDISC-ODM, XML, Data Standards, Web Development, Software Development, Pharmaceuticals, SAS/SQL, XML Tools, Pharmaceutical Industry, SAS programming, Programming, SDTM, Biostatistics, Clinical Trials, SAS Programming, Clinical Research
Education
Eindhoven University of Technology 1980 — 1988
MS, Mathematics
Van der Puttlyceum, Eindhoven 1974 — 1980
VWO (Atheneum)
SAS Institute Inc. February 2011 - Present
CDISC June 2008 - Present
lexjansen.com July 2003 - Present
Octagon Research Solutions June 2008 - February 2011
Take Solutions Inc. July 2007 - June 2008
Organon USA Inc. April 2004 - July 2007
NV Organon January 1992 - March 2004
Statistics Netherlands (CBS) September 1990 - December 1991
Skills
SAS, CDISC, CDISC Define-XML, CDISC-ODM, XML, Data Standards, Web Development, Software Development, Pharmaceuticals, SAS/SQL, XML Tools, Pharmaceutical Industry, SAS programming, Programming, SDTM, Biostatistics, Clinical Trials, SAS Programming, Clinical Research
Education
Eindhoven University of Technology 1980 — 1988
MS, Mathematics
Van der Puttlyceum, Eindhoven 1974 — 1980
VWO (Atheneum)
Andrea Vadakin Andrea Vadakin's CDISC Experience May 2015 - Present
Job Director of Communications and Public Relations at CDISC
Industry Nonprofit Organization Management
Experience
CDISC May 2015 - Present
CDISC October 2011 - May 2015
Kansas Kids @ GEAR UP July 2010 - October 2011
U.S. Department of Commerce, Census Bureau February 2010 - July 2010
Thunderbird School of Global Management August 2008 - December 2009
United Nations Industrial Development Organization May 2009 - August 2009
Japan Exchange and Teaching Program(me) (JET) July 2006 - July 2007
Skills
Project Management, Annual Reports, Press Releases, Fundraising, Social Media Marketing, Marketing Strategy, Strategic Communications, Collateral Materials..., Sponsorship Generation, Recruitment Advertising, Technical Writing, Budgets, Market Analysis, RFP, Procurement, Performance Measurement, Business Analytics, Political Risk Analysis, Grant Writing, Vocus, Proposal Writing
Education
Thunderbird School of Global Management 2008 — 2009
MA, Global Affairs and Management
Wichita State University 2002 — 2005
BA, English Language and Literature
CDISC May 2015 - Present
CDISC October 2011 - May 2015
Kansas Kids @ GEAR UP July 2010 - October 2011
U.S. Department of Commerce, Census Bureau February 2010 - July 2010
Thunderbird School of Global Management August 2008 - December 2009
United Nations Industrial Development Organization May 2009 - August 2009
Japan Exchange and Teaching Program(me) (JET) July 2006 - July 2007
Skills
Project Management, Annual Reports, Press Releases, Fundraising, Social Media Marketing, Marketing Strategy, Strategic Communications, Collateral Materials..., Sponsorship Generation, Recruitment Advertising, Technical Writing, Budgets, Market Analysis, RFP, Procurement, Performance Measurement, Business Analytics, Political Risk Analysis, Grant Writing, Vocus, Proposal Writing
Education
Thunderbird School of Global Management 2008 — 2009
MA, Global Affairs and Management
Wichita State University 2002 — 2005
BA, English Language and Literature
Kaci Wood's CDISC Experience October 2014 - Present
Job Administrative Assistant at CDISC
Industry Pharmaceuticals
Experience
CDISC October 2014 - Present
Regions Financial Corporation September 2012 - October 2014
Iberia Bank April 2011 - September 2012
Skills
Technical Writing, Community Outreach, Commercial Banking, Organizational..., Customer Service, Commercial Lending, Loans, Credit Analysis, Lines Of Credit, Deposits, Credit, Small Business Lending, Banking, Consumer Lending, Mortgage Lending, Finance, Financial Analysis, Retail Banking, Microsoft Office, Management, Sales, Public Speaking, Microsoft Excel
Education
Louisiana Tech University 2007 — 2011
Bachelor of Arts (B.A.), Psychology
CDISC October 2014 - Present
Regions Financial Corporation September 2012 - October 2014
Iberia Bank April 2011 - September 2012
Skills
Technical Writing, Community Outreach, Commercial Banking, Organizational..., Customer Service, Commercial Lending, Loans, Credit Analysis, Lines Of Credit, Deposits, Credit, Small Business Lending, Banking, Consumer Lending, Mortgage Lending, Finance, Financial Analysis, Retail Banking, Microsoft Office, Management, Sales, Public Speaking, Microsoft Excel
Education
Louisiana Tech University 2007 — 2011
Bachelor of Arts (B.A.), Psychology
Liz Nulton-Bodiford Liz Nulton-Bodiford's CDISC Experience 2006 - 2010
Job Manager, Regulatory Affairs Quality Assurance at GSK
Industry Pharmaceuticals
Experience
North Carolina Chapter of the Society of Quality Assurance January 2015 - Present
GSK January 2015 - Present
GSK November 2013 - Present
GlaxoSmithKline May 2012 - November 2013
GlaxoSmithKline 2010 - 2012
CDISC 2006 - 2010
GlaxoSmithKline 2001 - 2010
GlaxoWellcome 1996 - 2001
Burroughs Wellcome June 1990 - 1996
Skills
Training, Clinical Development, Pharmaceutical Industry, Clinical Data Management, Drug Safety, Clinical Trials, CDISC, Document Management, IND, Clinical Research, Quality Assurance, CRO, GCP, 21 CFR Part 11, Computer System..., Sop, CTMS, EDC, Regulatory Submissions, Validation, Regulatory Affairs, Data Management, FDA, SOP
Education
Campbell University 2006 — 2011
Masters of Science, Clinical Research
Emory and Henry College 1986 — 1990
Bachelors, Mass Communications, Visual Art
North Carolina Chapter of the Society of Quality Assurance January 2015 - Present
GSK January 2015 - Present
GSK November 2013 - Present
GlaxoSmithKline May 2012 - November 2013
GlaxoSmithKline 2010 - 2012
CDISC 2006 - 2010
GlaxoSmithKline 2001 - 2010
GlaxoWellcome 1996 - 2001
Burroughs Wellcome June 1990 - 1996
Skills
Training, Clinical Development, Pharmaceutical Industry, Clinical Data Management, Drug Safety, Clinical Trials, CDISC, Document Management, IND, Clinical Research, Quality Assurance, CRO, GCP, 21 CFR Part 11, Computer System..., Sop, CTMS, EDC, Regulatory Submissions, Validation, Regulatory Affairs, Data Management, FDA, SOP
Education
Campbell University 2006 — 2011
Masters of Science, Clinical Research
Emory and Henry College 1986 — 1990
Bachelors, Mass Communications, Visual Art
Nicole Harmon, Ph.D. Nicole Harmon, Ph.D.'s CDISC Experience February 2015 - Present
Job Executive Director at CDISC
Industry Nonprofit Organization Management
Experience
CDISC February 2015 - Present
Texas Hospital Association June 2013 - February 2015
Texas Healthcare Trustees June 2013 - February 2015
CORE Health Foundation May 2010 - May 2013
CORE Health Care August 2007 - May 2010
National Kidney Foundation of West Texas June 2003 - October 2007
American Cancer Society 2000 - 2003
Skills
Community Outreach, Non-profits, Business Development, Marketing, Public Health, Health Care, Corporate Communications, Physician Relations, Strategic Partnerships, Organizational..., Strategic Policy..., Community Engagement, Grant Writing, Grant Administration, Fundraising, Event Planning, Program Development, Public Speaking, Teaching, Nonprofits, Healthcare, Management, Program Evaluation, Research, Volunteer Management, Leadership Development, Proposal Writing, Public Policy, Community Development, Policy, Workshop Facilitation, Policy Analysis, Strategic Planning, Leadership, Grants, Program Management, Public Relations
Education
Texas Tech University
Ph.D., Counselor Education & Supervision
Texas State University-San Marcos 2000 — 2003
Master of Arts (M.A.), Marriage & Family Therapy
CDISC February 2015 - Present
Texas Hospital Association June 2013 - February 2015
Texas Healthcare Trustees June 2013 - February 2015
CORE Health Foundation May 2010 - May 2013
CORE Health Care August 2007 - May 2010
National Kidney Foundation of West Texas June 2003 - October 2007
American Cancer Society 2000 - 2003
Skills
Community Outreach, Non-profits, Business Development, Marketing, Public Health, Health Care, Corporate Communications, Physician Relations, Strategic Partnerships, Organizational..., Strategic Policy..., Community Engagement, Grant Writing, Grant Administration, Fundraising, Event Planning, Program Development, Public Speaking, Teaching, Nonprofits, Healthcare, Management, Program Evaluation, Research, Volunteer Management, Leadership Development, Proposal Writing, Public Policy, Community Development, Policy, Workshop Facilitation, Policy Analysis, Strategic Planning, Leadership, Grants, Program Management, Public Relations
Education
Texas Tech University
Ph.D., Counselor Education & Supervision
Texas State University-San Marcos 2000 — 2003
Master of Arts (M.A.), Marriage & Family Therapy
Abhishek Dabral's CDISC Experience January 2014 - Present
Job Biometrics| Data Standards | Statistical / Clinical Programming| Bioinformatics
Industry Pharmaceuticals
Experience
Allergan (Formerly Actavis/Forest Labs) March 2009 - Present
CDISC January 2014 - Present
TransCelerate BioPharma Inc. 2015 - Present
Sanofi Pasteur June 2007 - March 2009
Bristol-Myers Squibb April 2006 - June 2007
Centers for Disease Control July 2004 - July 2005
Skills
Clinical Data Management, SAS, Data Management, CDISC, Clinical Data Standards, Databases, Clinical Trials, Biostatistics, Statistical Programming, Data Analysis, Clinical Research, FDA, Biotechnology, CRO, Clinical Development, Pharmaceutical Industry, GCP, SAS Programming
Education
Georgia Institute of Technology 2004 — 2005
Master of Science (MS), Bioinformatics
Delhi University
Bachelor of Information Technology, Major: Computer Science
Allergan (Formerly Actavis/Forest Labs) March 2009 - Present
CDISC January 2014 - Present
TransCelerate BioPharma Inc. 2015 - Present
Sanofi Pasteur June 2007 - March 2009
Bristol-Myers Squibb April 2006 - June 2007
Centers for Disease Control July 2004 - July 2005
Skills
Clinical Data Management, SAS, Data Management, CDISC, Clinical Data Standards, Databases, Clinical Trials, Biostatistics, Statistical Programming, Data Analysis, Clinical Research, FDA, Biotechnology, CRO, Clinical Development, Pharmaceutical Industry, GCP, SAS Programming
Education
Georgia Institute of Technology 2004 — 2005
Master of Science (MS), Bioinformatics
Delhi University
Bachelor of Information Technology, Major: Computer Science
Sara Shafer Sara Shafer's CDISC Experience April 2015 - Present
Job Communications and Events Specialist at CDISC
Industry Nonprofit Organization Management
Experience
CDISC April 2015 - Present
Sitterle Homes November 2014 - April 2015
Hospitality Financial and Technology Professionals February 2013 - November 2014
Hospitality Financial and Technology Professionals August 2009 - February 2013
Hospitality Financial and Technology Professionals April 2009 - August 2009
Hospitality Financial and Technology Professionals January 2009 - April 2009
Skills
Event Management, Event Planning, Press Releases, Project Coordination, Basic HTML, Newsletter Production, Microsoft Office, Management, Team Building, Volunteer Management, Data Entry, Adobe Creative Suite
Education
Concordia University-Austin 2007 — 2009
B.A., Communications, Public Relations
Austin Community College 2004 — 2007
General Studies, Communication
CDISC April 2015 - Present
Sitterle Homes November 2014 - April 2015
Hospitality Financial and Technology Professionals February 2013 - November 2014
Hospitality Financial and Technology Professionals August 2009 - February 2013
Hospitality Financial and Technology Professionals April 2009 - August 2009
Hospitality Financial and Technology Professionals January 2009 - April 2009
Skills
Event Management, Event Planning, Press Releases, Project Coordination, Basic HTML, Newsletter Production, Microsoft Office, Management, Team Building, Volunteer Management, Data Entry, Adobe Creative Suite
Education
Concordia University-Austin 2007 — 2009
B.A., Communications, Public Relations
Austin Community College 2004 — 2007
General Studies, Communication
Stephen Ruberg Stephen Ruberg's CDISC Experience 2001 - 2007
Job Fellow of American Statistical Association
Industry Pharmaceuticals
Experience
Eli Lilly October 2010 - Present
Purdue University July 2009 - Present
Marian University Indianapolis June 2007 - Present
National eHealth Collaborative October 2008 - December 2009
Eli Lilly March 2000 - December 2007
CDISC 2001 - 2007
Quintiles 1999 - 2000
Hoechst Marion Roussel 1996 - 1999
HMR 1995 - 1999
Marion Merrell Dow Pharmaceuticals 1994 - 1996
Skills
Statistics, Drug Development, Applied Mathematics, Biostatistics, Clinical Trials, Bioinformatics, Clinical Development, Science, Clinical Research, Pharmaceutical Industry, Statistical Modeling, Leadership, Data Management, Life Sciences, Data Mining, Strategy, Lifesciences, Clinical Study Design, Biomarkers, Biotechnology, Analytics, R&D, CRO, Epidemiology
Education
University of Cincinnati College of Medicine 1981 — 1984
PhD, Biostatistics
Miami University 1978 — 1980
MS, Statistics
Thomas More College 1974 — 1978
BA, Mathematics
Eli Lilly October 2010 - Present
Purdue University July 2009 - Present
Marian University Indianapolis June 2007 - Present
National eHealth Collaborative October 2008 - December 2009
Eli Lilly March 2000 - December 2007
CDISC 2001 - 2007
Quintiles 1999 - 2000
Hoechst Marion Roussel 1996 - 1999
HMR 1995 - 1999
Marion Merrell Dow Pharmaceuticals 1994 - 1996
Skills
Statistics, Drug Development, Applied Mathematics, Biostatistics, Clinical Trials, Bioinformatics, Clinical Development, Science, Clinical Research, Pharmaceutical Industry, Statistical Modeling, Leadership, Data Management, Life Sciences, Data Mining, Strategy, Lifesciences, Clinical Study Design, Biomarkers, Biotechnology, Analytics, R&D, CRO, Epidemiology
Education
University of Cincinnati College of Medicine 1981 — 1984
PhD, Biostatistics
Miami University 1978 — 1980
MS, Statistics
Thomas More College 1974 — 1978
BA, Mathematics
Lou Ann Kramer's CDISC Experience 2005 - Present
Job Vice President, Instem
Industry Information Technology and Services
Experience
Instem March 2015 - Present
CDISC 2005 - Present
Eli Lilly and Company January 2015 - Present
Eli Lilly and Company February 1998 - December 2014
CDISC 2001 - May 2005
Eli Lilly October 1992 - January 1998
Eli Lilly - Medical Info. Systems 1990 - 1992
Eli Lilly and Company 1988 - 1990
Lilly Research Laboratories June 1984 - January 1988
Skills
Pharmaceutical Industry, Computer System..., Clinical Development, CRO, Regulatory Submissions, Clinical Trials, Leadership, CDISC, IT Operations, IT Recruitment, Research, Desktop Publishing, eCTD, NDA, IND, Team Management, Team Leadership, Global Cross-Functional..., Cross-functional Team..., Vendor Management, Process Improvement, Computer Science, Community Outreach, Community Partnership..., Scientific Computing, GLP, Biotechnology, Life Sciences
Education
Indiana University-Purdue University at Indianapolis 1980 — 1984
B.S., Computer Science & Pure Mathematics
Instem March 2015 - Present
CDISC 2005 - Present
Eli Lilly and Company January 2015 - Present
Eli Lilly and Company February 1998 - December 2014
CDISC 2001 - May 2005
Eli Lilly October 1992 - January 1998
Eli Lilly - Medical Info. Systems 1990 - 1992
Eli Lilly and Company 1988 - 1990
Lilly Research Laboratories June 1984 - January 1988
Skills
Pharmaceutical Industry, Computer System..., Clinical Development, CRO, Regulatory Submissions, Clinical Trials, Leadership, CDISC, IT Operations, IT Recruitment, Research, Desktop Publishing, eCTD, NDA, IND, Team Management, Team Leadership, Global Cross-Functional..., Cross-functional Team..., Vendor Management, Process Improvement, Computer Science, Community Outreach, Community Partnership..., Scientific Computing, GLP, Biotechnology, Life Sciences
Education
Indiana University-Purdue University at Indianapolis 1980 — 1984
B.S., Computer Science & Pure Mathematics
Marcelina Hungria's CDISC Experience November 2008 - Present
Job CDISC / SAS Data Submission Consulting Services; CDISC Gold Member & RSP
Industry Pharmaceuticals
Experience
DIcore Group, LLC February 2011 - Present
CDISC November 2008 - Present
Image Solutions, Inc. November 2007 - February 2011
Image Solutions, Inc. 2007 - 2008
Johnson & Johnson July 2002 - November 2007
Novartis Pharmaceuticals 1994 - 1997
Schering-Plough Pharmaceuticals 1994 - 1994
Skills
CDISC, SAS programming, Validation, Pharmaceutical Industry, Data Management, SAS, FDA, 21 CFR Part 11, Clinical Research, Clinical Data Management, Sop, Lifesciences, Document Management, Vendor Management, Computer System..., Database Design, Regulatory Affairs, Data Warehousing, Regulatory Submissions, Clinical Trials, Business Intelligence, SDTM, CRO, Integration, Protocol, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark 1989 — 1991
MBA
Universidad Simón Bolívar 1971 — 1976
Software Engineer, Computer Science
DIcore Group, LLC February 2011 - Present
CDISC November 2008 - Present
Image Solutions, Inc. November 2007 - February 2011
Image Solutions, Inc. 2007 - 2008
Johnson & Johnson July 2002 - November 2007
Novartis Pharmaceuticals 1994 - 1997
Schering-Plough Pharmaceuticals 1994 - 1994
Skills
CDISC, SAS programming, Validation, Pharmaceutical Industry, Data Management, SAS, FDA, 21 CFR Part 11, Clinical Research, Clinical Data Management, Sop, Lifesciences, Document Management, Vendor Management, Computer System..., Database Design, Regulatory Affairs, Data Warehousing, Regulatory Submissions, Clinical Trials, Business Intelligence, SDTM, CRO, Integration, Protocol, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark 1989 — 1991
MBA
Universidad Simón Bolívar 1971 — 1976
Software Engineer, Computer Science
Sally Cassells's CDISC Experience 1999 - 2010
Job Clinical Research and Healthcare Informatics
Industry Computer Software
Experience
Self employed 2011 - Present
PhaseForward 2005 - 2010
CDISC 1999 - 2010
SCDM 2003 - 2003
PHT Corporation 2000 - 2002
Belmont Research 1997 - 2000
BBN 1985 - 1997
Skills
CDISC, Clinical Trials, Pharmaceuticals, Software Design, XML Tools, Databases, Bayesian statistics, Drug Development
Education
Harvard School of Public Health
SM, Biostatistics
McGill University
BS, Mathematics
Self employed 2011 - Present
PhaseForward 2005 - 2010
CDISC 1999 - 2010
SCDM 2003 - 2003
PHT Corporation 2000 - 2002
Belmont Research 1997 - 2000
BBN 1985 - 1997
Skills
CDISC, Clinical Trials, Pharmaceuticals, Software Design, XML Tools, Databases, Bayesian statistics, Drug Development
Education
Harvard School of Public Health
SM, Biostatistics
McGill University
BS, Mathematics
Jane Diefenbach's CDISC Experience 2004 - 2008
Job Data Standards for Clinical Research
Industry Biotechnology
Experience
PharmaStat LLC 2005 - Present
CDISC 2004 - 2008
Quintiles, BRI 1990 - 2008
Quintiles May 1990 - December 1999
Skills
Data Standards, Data Management, Statistical Programming, Biostatistics, CDISC, SDTM
Education
Cornell University
Bachelor's Degree, Biology
University of Maryland College Park
Master's Degree, Plant Genetics
PharmaStat LLC 2005 - Present
CDISC 2004 - 2008
Quintiles, BRI 1990 - 2008
Quintiles May 1990 - December 1999
Skills
Data Standards, Data Management, Statistical Programming, Biostatistics, CDISC, SDTM
Education
Cornell University
Bachelor's Degree, Biology
University of Maryland College Park
Master's Degree, Plant Genetics
Michael Crayne's CDISC Experience 1997 - 1998
Job Healthcare IT Consultant
Industry Information Technology and Services
Experience
Crayne Consulting December 2005 - Present
Phoenix Data Systems 1998 - 2005
CDISC 1997 - 1998
SmithKline Beecham 1995 - 1998
Skills
Clinical Data Management, 21 CFR Part 11, Leadership, Databases, Agile Methodologies, IT Strategy, Integration, Data Entry, EDC, SQL, Clinical Trials, Data Management, Software Project..., Quality Assurance, Software Documentation, Biotechnology
Education
Open University 1994 — 1995
Software Engineering, Software Engineering and Manufacturing (Dual)
National University, San Diego, Ca 1983 — 1984
Computer Science
Crayne Consulting December 2005 - Present
Phoenix Data Systems 1998 - 2005
CDISC 1997 - 1998
SmithKline Beecham 1995 - 1998
Skills
Clinical Data Management, 21 CFR Part 11, Leadership, Databases, Agile Methodologies, IT Strategy, Integration, Data Entry, EDC, SQL, Clinical Trials, Data Management, Software Project..., Quality Assurance, Software Documentation, Biotechnology
Education
Open University 1994 — 1995
Software Engineering, Software Engineering and Manufacturing (Dual)
National University, San Diego, Ca 1983 — 1984
Computer Science
Audrey Walker's CDISC Experience June 2009 - Present
Job Associate Director, Electronic Submissions, IT at Charles River Laboratories
Industry Biotechnology
Experience
Charles River Laboratories June 2015 - Present
CDISC June 2009 - Present
Charles River Laboratories April 2013 - June 2015
Charles River Laboratories April 2011 - April 2013
Charles River Laboratories August 2008 - April 2011
Charles River Laboratories 2006 - 2008
Charles River Laboratories 2004 - 2006
CTBR BioResearch Inc. 2002 - 2004
CTBR BioResearch Inc. 1998 - 2002
ClinTrials BioResearch Ltd. 1997 - 1998
Skills
Data Management, CDISC, Data Analysis, Business Analysis, Requirements Analysis, Data Standards, Standards Development, GLPs, 21 CFR Part 11, Computer System..., Business Process..., Problem Solving, Validation, FDA, Sop, EDC, GCP, LIMS, Visio, Drug Development, CTMS, Clinical Trials, Clinical Data Management, GxP, Toxicology, Quality Assurance, SDTM, Document Management, SAS, Change Control, Clinical Development, Testing, Analysis, SharePoint, CRO, SDLC, Software Documentation, Lifesciences, Biotechnology, GLP, Pharmaceutical Industry, Informatics, IND
Education
CEGEP - John Abbott College 1995 — 1997
DEC, Office Systems Management
Dawson College 1994 — 1996
Office Management
Charles River Laboratories June 2015 - Present
CDISC June 2009 - Present
Charles River Laboratories April 2013 - June 2015
Charles River Laboratories April 2011 - April 2013
Charles River Laboratories August 2008 - April 2011
Charles River Laboratories 2006 - 2008
Charles River Laboratories 2004 - 2006
CTBR BioResearch Inc. 2002 - 2004
CTBR BioResearch Inc. 1998 - 2002
ClinTrials BioResearch Ltd. 1997 - 1998
Skills
Data Management, CDISC, Data Analysis, Business Analysis, Requirements Analysis, Data Standards, Standards Development, GLPs, 21 CFR Part 11, Computer System..., Business Process..., Problem Solving, Validation, FDA, Sop, EDC, GCP, LIMS, Visio, Drug Development, CTMS, Clinical Trials, Clinical Data Management, GxP, Toxicology, Quality Assurance, SDTM, Document Management, SAS, Change Control, Clinical Development, Testing, Analysis, SharePoint, CRO, SDLC, Software Documentation, Lifesciences, Biotechnology, GLP, Pharmaceutical Industry, Informatics, IND
Education
CEGEP - John Abbott College 1995 — 1997
DEC, Office Systems Management
Dawson College 1994 — 1996
Office Management
Kent Letourneau's CDISC Experience 2015 - 2015
Job Senior Director, Global Head, Data Standards at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences July 2014 - Present
CDISC 2015 - 2015
CDISC 2015 - 2015
PRA International June 2011 - July 2014
PRA International June 2009 - June 2011
PRA International March 2008 - May 2009
PRA Health Sciences June 2004 - March 2008
PRA Health Sciences June 2002 - June 2004
PRA Health Sciences February 1999 - June 2002
PRA Health Sciences August 1995 - February 1999
Skills
Biostatistics, EDC, CRO, SAS, CDISC, Clinical Trials, SAS programming, SDTM, Statistical Programming, ICH-GCP, Pharmaceutical Industry, Validation, Regulatory Submissions, Biotechnology, Analysis, Oncology, GCP, Clinical Development, 21 CFR Part 11, Statistics, Programming, Therapeutic Areas, CTMS, Regulatory Affairs, Clinical Study Design, Vaccines, Sop, Clinical Research, Drug Development, Clinical Data Management, Pharmacovigilance, Inform, FDA, CRF design, Clinical Monitoring, Protocol, Oracle Clinical, Infectious Diseases, Phase I, Regulatory Requirements, Medidata, Biopharmaceuticals, Clinical Operations, Immunology, Patient Recruitment
Education
Kansas State University 1992 — 1994
Master of Science in Statistics
Kansas State University 1985 — 1989
Bachelor of Science, Secondary Education - Mathematics
PRA Health Sciences July 2014 - Present
CDISC 2015 - 2015
CDISC 2015 - 2015
PRA International June 2011 - July 2014
PRA International June 2009 - June 2011
PRA International March 2008 - May 2009
PRA Health Sciences June 2004 - March 2008
PRA Health Sciences June 2002 - June 2004
PRA Health Sciences February 1999 - June 2002
PRA Health Sciences August 1995 - February 1999
Skills
Biostatistics, EDC, CRO, SAS, CDISC, Clinical Trials, SAS programming, SDTM, Statistical Programming, ICH-GCP, Pharmaceutical Industry, Validation, Regulatory Submissions, Biotechnology, Analysis, Oncology, GCP, Clinical Development, 21 CFR Part 11, Statistics, Programming, Therapeutic Areas, CTMS, Regulatory Affairs, Clinical Study Design, Vaccines, Sop, Clinical Research, Drug Development, Clinical Data Management, Pharmacovigilance, Inform, FDA, CRF design, Clinical Monitoring, Protocol, Oracle Clinical, Infectious Diseases, Phase I, Regulatory Requirements, Medidata, Biopharmaceuticals, Clinical Operations, Immunology, Patient Recruitment
Education
Kansas State University 1992 — 1994
Master of Science in Statistics
Kansas State University 1985 — 1989
Bachelor of Science, Secondary Education - Mathematics
Carlo Radovsky's CDISC Experience May 2009 - Present
Job •Managing Partner and Founder at etera solutions
Industry Biotechnology
Experience
CDISC May 2009 - Present
etera solutions, LLC 2008 - Present
SCDM April 2011 - 2012
Vertex Pharmaceuticals 2007 - 2008
EMD Serono April 2004 - September 2007
Millennium Pharmaceuticals August 2002 - March 2004
Self-employed August 1997 - July 2002
PAREXEL 1994 - 1997
Skills
Pharmaceutical Industry, Standards Adoption and..., CDISC Modelling, CDISC Conversions, Metadata Repository..., CDASH, ODM, SDTM, ADaM, define.xml, define.pdf, Statistical Programming, SAS, 21 CRF Part 11, XML, Clinical Data Management, Data Management, CDISC, 21 CFR Part 11
Education
University of Massachusetts, Amherst 1991 — 1993
Computer Studies and Comparative Literature
Northeastern University 1985 — 1987
Computer Science
CDISC May 2009 - Present
etera solutions, LLC 2008 - Present
SCDM April 2011 - 2012
Vertex Pharmaceuticals 2007 - 2008
EMD Serono April 2004 - September 2007
Millennium Pharmaceuticals August 2002 - March 2004
Self-employed August 1997 - July 2002
PAREXEL 1994 - 1997
Skills
Pharmaceutical Industry, Standards Adoption and..., CDISC Modelling, CDISC Conversions, Metadata Repository..., CDASH, ODM, SDTM, ADaM, define.xml, define.pdf, Statistical Programming, SAS, 21 CRF Part 11, XML, Clinical Data Management, Data Management, CDISC, 21 CFR Part 11
Education
University of Massachusetts, Amherst 1991 — 1993
Computer Studies and Comparative Literature
Northeastern University 1985 — 1987
Computer Science
Alec Vardy's CDISC Experience 2007 - Present
Job Senior Director, Data Management at Jazz Pharmaceuticals
Industry Pharmaceuticals
Experience
Jazz Pharmaceuticals August 2015 - Present
CDISC 2007 - Present
FibroGen, Inc. October 2014 - August 2015
Onyx Pharmaceuticals April 2013 - September 2014
Affymax, Inc. February 2010 - April 2013
Exelixis July 2008 - January 2010
Independent Consultant July 2007 - July 2008
CV Therapeutics 2002 - 2007
SCDM 2002 - 2004
PPD November 2000 - April 2002
Skills
Clinical Trials, SOP, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Data Management, CDM, CRO, Regulatory Affairs, 21 CFR Part 11, CDISC, SAS, Drug Development, Biotechnology, Sop, CTMS, SDTM, CRF design, Data Management, EDC, GCP, Clinical Development, Clinical Study Design, Regulatory Submissions, ICH-GCP, Computer System..., Therapeutic Areas, Oracle Clinical, FDA, SAS programming, Biostatistics, Infectious Diseases, Lifesciences, Validation, Pharmacovigilance, Medical Writing, Vaccines, Inform, Protocol, SAS Programming, Life Sciences
Education
The University of Edinburgh 1971 — 1973
MPhil, Statistics
Portsmouth University 1968 — 1971
BSc, Mathematics
Jazz Pharmaceuticals August 2015 - Present
CDISC 2007 - Present
FibroGen, Inc. October 2014 - August 2015
Onyx Pharmaceuticals April 2013 - September 2014
Affymax, Inc. February 2010 - April 2013
Exelixis July 2008 - January 2010
Independent Consultant July 2007 - July 2008
CV Therapeutics 2002 - 2007
SCDM 2002 - 2004
PPD November 2000 - April 2002
Skills
Clinical Trials, SOP, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Data Management, CDM, CRO, Regulatory Affairs, 21 CFR Part 11, CDISC, SAS, Drug Development, Biotechnology, Sop, CTMS, SDTM, CRF design, Data Management, EDC, GCP, Clinical Development, Clinical Study Design, Regulatory Submissions, ICH-GCP, Computer System..., Therapeutic Areas, Oracle Clinical, FDA, SAS programming, Biostatistics, Infectious Diseases, Lifesciences, Validation, Pharmacovigilance, Medical Writing, Vaccines, Inform, Protocol, SAS Programming, Life Sciences
Education
The University of Edinburgh 1971 — 1973
MPhil, Statistics
Portsmouth University 1968 — 1971
BSc, Mathematics
Laura DiTullio's CDISC Experience 2007 - Present
Job Senior CDISC Consultant at TAKE Solutions
Industry Pharmaceuticals
Experience
TAKE Solutions August 2011 - Present
CDISC 2007 - Present
GE Healthcare February 2003 - December 2009
Bristol-Myers Squibb 1998 - 2003
Skills
SAS, CDISC, Statistical Programming, Data Management, SAS programming, Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Data Management, FDA, Medical Devices, GCP, Sop, Therapeutic Areas, EDC, Validation, Clinical Development, CTMS, 21 CFR Part 11, Lifesciences, Oracle Clinical, CRO, Pharmacovigilance, Computer System..., Oncology, Protocol, Biotechnology, ICH-GCP, SAS Programming
Education
Fairleigh Dickinson University
MPA, Management
Philadelphia University
TAKE Solutions August 2011 - Present
CDISC 2007 - Present
GE Healthcare February 2003 - December 2009
Bristol-Myers Squibb 1998 - 2003
Skills
SAS, CDISC, Statistical Programming, Data Management, SAS programming, Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Data Management, FDA, Medical Devices, GCP, Sop, Therapeutic Areas, EDC, Validation, Clinical Development, CTMS, 21 CFR Part 11, Lifesciences, Oracle Clinical, CRO, Pharmacovigilance, Computer System..., Oncology, Protocol, Biotechnology, ICH-GCP, SAS Programming
Education
Fairleigh Dickinson University
MPA, Management
Philadelphia University
Chandra Wooten's CDISC Experience 2008 - Present
Job Senior Clinical Data Manager at Statistics & Data Corporation (SDC)
Industry Biotechnology
Experience
Statistics & Data Corporation (SDC) April 2013 - Present
CDISC 2008 - Present
SCDM 2003 - Present
Gilead Sciences September 2003 - March 2013
Chiron Corporation 2000 - 2003
ASG, Inc. 1999 - 2002
McGhan Medical Corp 1994 - 1999
Skills
Clinical Data Management, EDC, CRF design, CDISC, CRO, GCP, Oncology, Clinical Trials, Clinical Development, Clinical Research, CTMS, ICH-GCP, Data Management, Protocol, Sop, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11
Education
University of California, Santa Barbara
B.A., English
Statistics & Data Corporation (SDC) April 2013 - Present
CDISC 2008 - Present
SCDM 2003 - Present
Gilead Sciences September 2003 - March 2013
Chiron Corporation 2000 - 2003
ASG, Inc. 1999 - 2002
McGhan Medical Corp 1994 - 1999
Skills
Clinical Data Management, EDC, CRF design, CDISC, CRO, GCP, Oncology, Clinical Trials, Clinical Development, Clinical Research, CTMS, ICH-GCP, Data Management, Protocol, Sop, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11
Education
University of California, Santa Barbara
B.A., English
sam k's CDISC Experience January 2013 - Present
Job Executive Committee Member at OpenCDISC
Industry Pharmaceuticals
Experience
PharmaSUG May 2014 - Present
PhilaSUG January 2014 - Present
SAS August 2013 - Present
OpenCDISC July 2013 - Present
CDISC January 2013 - Present
AstraZeneca March 2012 - Present
Onyx Pharmaceuticals January 2010 - February 2012
Bristol-Myers Squibb January 2009 - December 2010
Skills
Clinical Data Management, Clinical Trials, SAS, Oncology, Biostatistics, Oracle Clinical, CTMS, Biotechnology, FDA, Sop, Lifesciences, Pharmacovigilance, Clinical Research, SDTM, Regulatory Submissions, Drug Development
Education
Grand Valley State University
Master's degree
PharmaSUG May 2014 - Present
PhilaSUG January 2014 - Present
SAS August 2013 - Present
OpenCDISC July 2013 - Present
CDISC January 2013 - Present
AstraZeneca March 2012 - Present
Onyx Pharmaceuticals January 2010 - February 2012
Bristol-Myers Squibb January 2009 - December 2010
Skills
Clinical Data Management, Clinical Trials, SAS, Oncology, Biostatistics, Oracle Clinical, CTMS, Biotechnology, FDA, Sop, Lifesciences, Pharmacovigilance, Clinical Research, SDTM, Regulatory Submissions, Drug Development
Education
Grand Valley State University
Master's degree
Jyoti Pillay's CDISC Experience September 2008 - Present
Job
Industry Accounting
Experience
CDISC September 2008 - Present
Rockwell Trading October 2006 - September 2008
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, English, Windows, Outlook, Budgets, QuickBooks, Non Profit Tax Returns, Tax Preparation
Education
University of Pune 1987 — 1990
Accounting and Audit
CDISC September 2008 - Present
Rockwell Trading October 2006 - September 2008
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, English, Windows, Outlook, Budgets, QuickBooks, Non Profit Tax Returns, Tax Preparation
Education
University of Pune 1987 — 1990
Accounting and Audit
Benjamin Labout's CDISC Experience July 2014 - Present
Job Guest Services Representative at Blackberry Farm
Industry Hospitality
Experience
CDISC July 2014 - Present
Blackberry Farm August 2012 - June 2014
Skills
Hospitality Industry, Customer Service
Education
St Charles Community College 2014 — 2016
Associate's Degree, Network Security, 3.5
CDISC July 2014 - Present
Blackberry Farm August 2012 - June 2014
Skills
Hospitality Industry, Customer Service
Education
St Charles Community College 2014 — 2016
Associate's Degree, Network Security, 3.5
Partners HealthCare
WellStar Health System
National Geographic Society
BJC HealthCare
Christiana Care Health System
NPR
Howard Hughes Medical Institute
AAA