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The EMB Team
EMB Biostatisticians have extensive experience in many different therapeutic areas. Our statisticians have successfully directed an exceptional number of intricate and diverse studies.
EMB Data Managers are specialists in organizing data for analysis and reporting, managing complicated studies, adapting databases to dynamic changes, and developing time-saving software.
The EMB Team Principal Members are:
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Edward F. Brown, PhD,
Executive Director |
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28+ years managing/reporting medical research data
27+ years using and teaching SAS
22+ years participating in a CRO
27 years teaching: programming, informatics and biostatistics
4 NDAs, 2 as Data Management Team leader
40 peer-review journal articles
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Beverly B. Brown,
Director, Data Management |
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23+ years validating/integrating/reporting US and global data
23+ years designing/developing database specifi cations
23+ 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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Dawn DuBois,
Principal Biostatistician |
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16+ years serving as a Biostatistician
7 years with a large, global pharmaceutical company
9+ years with CROs
Specialist in the design, analysis, and reporting of Phase I-IV clinical trials.
6 NDAs including preparation of ISE and ISS components, responses to
submission questions from regulatory agencies worldwide, and participation
in FDA Advisory Panel presentation.
16+ years SAS experience
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Denna Sweeney,
Principal Data Manager |
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6 years with large, global pharmaceutical companies
13+ years managing,
reviewing, auditing research data
13+ years data coordination
experience
13+ years experience
with diverse PC applications
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Karla A. McKenzie,
Senior Biostatistician |
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17+ years programming, managing and reporting data
14+ years design/analyzing/reporting research data
10 years with large, global pharmaceutical companies
14+ years SAS experience
10+ years analyzing and reporting of Phase I, III clinical trials; performed
analyses and report writing for drugs relating to schizophrenia, GI, allergies,
neurology, cardiovascular, oncology and respiratory
4 NDAs: report design, writing and review of ISS & ISE components
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Judy Seim,
Manager, Data Entry |
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30+ years Managing/analyzing/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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Marcia Wrona, Principal Database Programmer |
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27+ years SAS programming experience
28+ years managing and reporting medical research data
22+ years participating in a university-based CRO
22+ years teaching programming, informatics and biostatistics
Top Back |
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Michael C. Mosier, PhD,
Director, Biostatistics |
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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
17+ years SAS programming experience
29 published abstracts
23 peer-review publications (published or in press)
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Bruce Morrill, Principal Biostatistician |
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15+ years with a large, global pharmaceutical
company
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
25+ years SAS experience
8 peer-review publications
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Bill Stewart, PhD,
Distinguished Biostatistician |
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21+ years Pharmaceutical
industry experience
14+ years Big Pharma
experience
7 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 ratio
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Brenda Bishop, MBA, Director, Business Development |
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6+ years Business Development with CRO
15+ years SAS programming managing and reporting research data
9 years With a large, global pharmaceutical company
Project leader and FDA trainer on computer-aided NDAs
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Lori McConnell,
Director, Data Quality Assurance |
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15+ years working within the industry specializing in Data Management
6 years with a large, global pharmaceutical company
5 years with a large global CRO
8+ years data coordination experience
7+ years in a quality assurance role (e.g. hosting audits, developing SOPs)
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Marc Meyer,
Senior Statistical Programmer |
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16+ years SAS experience
16+ years analyzing and reporting research data
9+ 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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Suzanne Lassman, MPH,
Principal Statistical Programmer |
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17+ years managing/analyzing/reporting research data
17+ years SAS experience
5 years with a large, global pharmaceutical company
17+ years experience with diverse PC-based applications
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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