Edward F. Brown, PhD
Executive Director |
30 years managing and reporting medical research data
29 years using and teaching programming, informatics and biostatistics
28 years teaching: programming, informatics and biostatistics
24 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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17 years SAS experience
14 years serving as a biostatistician
10 years working in large, global pharmaceutical companies
4 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 |
18 years serving as a biostatistician
18 years SAS experience
11 years with CROs
7 years with a large, global pharmaceutical company
7 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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19 years programming, managing and reporting data
19 years SAS experience
16 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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18 years SAS experience
18 years analyzing and reporting research data
12 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 |
25 years SAS experience
25 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 |
20 years SAS programming experience
19 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
30 published abstracts
25 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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Amy L. Winters
Principal Statistical Programmer |
21 years SAS programming experience
9 years statistical programming experience in the pharmaceutical and
clinical research industry
Experience with many significant therapeutic areas: oncology, diabetes,
cardiac, autoimmune and more
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Beverly B. Brown
Director, Data Management
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25 years validating/integrating/reporting U.S. and global data
25 years designing/developing database specifications
25 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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12 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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Judith A. Seim
Manager, Data Entry |
35 years managing and 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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15 years managing, reviewing, auditing research data
15 years data coordination experience
15 years experience with diverse PC applications
6 years with large, global pharmaceutical companies
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Marcia D. Wrona
Principal Database Programmer |
30 years managing and reporting medical research data
29 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
6 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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17 years working within the industry specializing in data management
8 years data coordination experience
9 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 |
11 years in Information Technology
8 years managing IT at major university medical center
6 years as IT Manager for CRO
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