Edward F. Brown, PhD
Executive Director |
31 years managing and reporting medical research data
30 years using and teaching programming, informatics and biostatistics
30 years teaching: programming, informatics and biostatistics
25 years participating in a CRO
4 NDAs, 2 as Data Management Team leader
40 peer-review journal articles
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Elizabeth Dennis
Senior Statistical Programmer
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22 years SAS programming experience
17 years reporting medical research data
16 years in the pharmaceutical environment
12 years participating in a CRO
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David W. Donley, PhD
Principal Biostatistician
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18 years SAS experience
15 years serving as a biostatistician
10 years working in large, global pharmaceutical companies
5 years experience with CROs
2 NDAs including 1 as the Statistical Team Leader
7 peer-reviewed publications
Specialist in the design, analysis and publication of Phase II-IV clinical
trials in osteoporosis and diabetes; multiple years of experience with trials
for fracture repair, cancer risk reduction, gynecology, sepsis and cognition;
consulted on numerous regulatory submission and responses to regulatory
authorities.
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Dawn M. DuBois, MS
Principal Biostatistician |
19 years serving as a biostatistician
19 years SAS experience
12 years with CROs
7 years with a large, global pharmaceutical company
8 NDAs including preparation of ISE and ISS components, responses to
submission questions from regulatory agencies worldwide, and participation
in FDA Advisory Panel presentation.
Specialist in the design, analysis, and reporting of Phase I-IV clinical trials.
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Sandra Hall, PhD
Senior Biostatistician
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10 years teaching mathematics and statistics
10 years SAS experience
8 years serving as a biostatistian
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Suzanne J. Maninger, MPH
Principal Statistical Programmer
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19 years managing/analyzing/reporting research data
19 years SAS experience
19 years experience with diverse PC-based applications
5 years with a large, global pharmaceutical company
4 NDAs as lead programmer, including preparation of ISE and ISS data
and reporting components and responses to submission questions from
regulatory agencies worldwide
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Karla A. McKenzie, MS
Senior Biostatistician
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20 years programming, managing and reporting data
20 years SAS experience
17 years in the design, analysis and reporting of research data
10 years with large, global pharmaceutical companies
10 years analyzing and reporting of Phase I, III clinical trials; performed analyses and report writing for drugs relating to schizophrenia, allergies, gastroenterology, neurology, oncology, cardiology and respiratory disease
4 NDAs: report design, writing and review of ISS & ISE components
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Marc Meyer, MS
Senior Statistical Programmer
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20 years SAS experience
20 years analyzing and reporting research data
13 years experience with CROs; 4 years with a large, global CRO
Experience with a large, global pharmaceutical company
NDA participation, including preparation of ISE and ISS components
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Bruce Morrill, MS
Principal Biostatistician |
30 years SAS experience
25 years specializing in design & analysis of Phase I-III clinical trials. Lead statistician for drugs relating to schizophrenia, cardiovascular system, oncology, respiratory, neurology, diabetes, GI and allergy
18 NDAs serving in the design, analysis and/or review of pre-clinical, Phase I-III, ISE or ISS components
15 years with a large, global pharmaceutical company
10 peer-review publications
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Michael C. Mosier, PhD
Director, Biostatistics |
21 years SAS programming experience
20 years serving as a biostatistician
6 years with a large, global pharmaceutical company specializing in the design & analysis of Phase II-III clinical trials; Lead Statistician for drugs relating to CNS and allergy
5 NDAs as the Biostatistics and Data Management Team leader
31 published abstracts
28 peer-review publications (published or in press)
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Belinda Pierson, MS
Senior Statistical Programmer |
8 years SAS experience
8 years analyzing and reporting research data
4 years experience with CROs; 3 years with a large, global CRO
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Jennifer Savage Sales, MS
Senior Statistical Programmer |
16 years SAS programming experience
13 years analyzing and reporting research data
10 years experience with CROs; 6 years with a large, global CRO
6 years experience with a large, global pharmaceutical company
NDA participation, including preparation of ISE and ISS components
Experience managing large, globally distributed team members and project teams
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Debra S. Schleusener, MS
Principal Biostatistician
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15 years experience in the pharmaceutical industry
2 NDAs including representation and defense to the FDA
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Bill Stewart, PhD
Distinguished Biostatistician |
21 years pharmaceutical industry experience
14 years big Pharma experience
9 years in CRO
7 NDAs as lead statistician
Published papers on survival analysis, categorical data analysis, dose response methods, and randomization-based interpretation of inference
Headed the statistics CV group at a large pharmaceutical company
Special work in hypertension for dose response, combination drugs, and estimation of trough/peak ratios
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Amy L. Winters
Principal Statistical Programmer |
13 years SAS programming experience
10 years statistical programming experience in the pharmaceutical and
clinical research industry
Experience with many significant therapeutic areas, including oncology, diabetes,
cardiology, and autoimmune
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Linda Bennett, MBA
Senior Data Manager |
21 years experience in data management
10 years working in the CRO industry
8 years data coordination experience
2 years experience handling EMB human resource needs
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Beverly B. Brown
Director, Data Management
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26 years validating/integrating/reporting U.S. and global data
26 years designing/developing database specifications
26 years SAS/SQL experience
12 years with a large, global pharmaceutical company
5 NDAs as lead programmer, including preparation of ISE, ISS and Section
11 components. Programming support for FDA panel review and FDA
response team
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Tracie J. Evans
Principal Data Manager |
13 years data management experience managing, reviewing, auditing
research data
10 years with a large global pharmaceutical clinical research
organization
Experience as the Lead Data Manager for global and U.S.-based trials
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Cora L. Jenkins
Data Manager
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25 years experience with diverse PC-based applications
24 years experience reviewing, managing and reporting medical research data
20 years participating in a CRO
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Kristin R. Pearson, CCDM
Principal Data Manager |
12 years data management experience, including managing/reviewing/auditing research data
12 years data coordination experience
11 years with a large, global CRO
Experience as lead data manager for global and U.S.-based clinical trials
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Judith A. Seim
Principal Data Manager |
36 years managing and reporting medical research data
20 years SAS programming experience
16 years participating in a university-based CRO
12 years study monitor/data manager of NIH grants
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Denna Sweeney
Principal Data Manager
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16 years managing, reviewing, auditing research data
16 years data coordination experience
16 years experience with diverse PC applications
6 years with large, global pharmaceutical companies
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Marcia D. Wrona
Principal Database Programmer |
31 years managing and reporting medical research data
30 years SAS programming experience
23 years participating in a university-based CRO
23 years teaching programming, informatics and biostatistics
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Brenda M. Bishop, MBA
Director, Business Development
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15 years SAS programming experience
15 years experience managing and reporting data
10 years leading EMB marketing activities
9 years with a large, global pharmaceutical company
7 years serving on the EMB Management Team
Project leader and FDA trainer for internal CANDA
Lead programmer on various project teams
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Lori A. McConnell
Director, Data Quality Assurance
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18 years working within the industry, specializing in data management
8 years data coordination experience
10 years in a quality assurance role (e.g. hosting audits, developing SOPs)
6 years with a large, global pharmaceutical company
5 years with a large global CRO
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Jeremy A. Pennington
Manager, Information Technology |
12 years experience in information technology
9 years managing information technology at major academic health center
7 years as IT Manager for CRO
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