Edward F. Brown, PhD
Executive Director |
29 years managing/reporting medical research data
28 years using and teaching SAS
28 years teaching: programming, informatics and biostatistics
23 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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21 years SAS programming experience
16 years reporting medical research data
15 years in the pharmaceutical environment
11 years participating in a CRO
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David W. Donley, PhD
Principal Biostatistician
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16 years SAS experience
13 years serving as a Biostatistician
10 years working in large, global pharmaceutical companies
3 years 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; experience with trials for fracture repair, cancer risk reduction, gynecology, cardiology, and cognition
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Dawn M. DuBois, MS
Principal Biostatistician
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17 years serving as a Biostatistician
17 years SAS experience
10 years with CROs
7 years with a large, global pharmaceutical company
6 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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Suzanne J. Maninger, MPH
Principal Statistical Programmer
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18 years managing/analyzing/reporting research data
18 years SAS experience
18 years experience with diverse PC-based applications
5 years with a large, global pharmaceutical company
3 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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18 years programming, managing and reporting data
18 years SAS experience
15 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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17 years SAS experience
17 years analyzing and reporting research data
10 years experience with CROs; 4 years with a large, global CRO
1 year with a large, global pharmaceutical company
NDA participation, including preparation of ISE and ISS components
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Bruce Morrill, MS
Principal Biostatistician |
25 years SAS experience
20 years specializing in design & analysis of Phase I-III clinical trials. Lead statistician for drugs relating to schizophrenia, cardiovascular, oncology, respiratory, neurology, diabetes, GI and allergy
18 NDAs: design, analysis and/or review of pre-clinical, Phase I, ISE, or ISS components
15 years with a large, global pharmaceutical company
8 peer-review publications
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Michael C. Mosier, PhD
Director, Biostatistics |
17 years SAS programming experience
16 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
29 published abstracts
23 peer-review publications (published or in press)
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Debra S. Schleusener, MS
Principal Biostatistician
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15 years experience in pharmaceutical industry
2 NDAs including representation/defense to 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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Beverly B. Brown
Director, Data Management
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24 years validating/integrating/reporting US and global data
24 years designing/developing database specifications
24 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, RHIA
Principal Data Manager
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11 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 US-based trials
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Judith A. Seim
Manager, Data Entry |
30 years managing/reporting medical research data 16 years participating in a university-based CRO 12 years study monitor/data manager of NIH grants
20 years SAS programming
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Denna Sweeney
Principal Data Manager
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14 years managing, reviewing, auditing research data
14 years data coordination experience
14 years experience with diverse PC applications
6 years with large, global pharmaceutical companies
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Marcia D. Wrona
Principal Database Programmer |
29 years managing and reporting medical research data
28 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, managing and reporting data
9 years with a large, global pharmaceutical company
8 years leading all EMB marketing activities
5 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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16 years working within the industry specializing in Data Management
8 years data coordination experience
8 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 |
10 years in Information Technology (IT)
7 years managing IT at major university medical center
5 years as IT Manager for CRO
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