BergumSTATS, LLC
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Statistical Consulting
Experience
President, BergumSTATS LLC (2012-Present)
Provide statistical consulting to industry primarily in the CMC (Chemistry, Manufacturing, and Control) areas within the pharmaceutical industry. Expertise in design/analysis of experiments, process validation acceptance criteria, sampling, stability design/analysis, specifications, and training.
Associate Director, Nonclinical Biostatistics (1995 - 2012)
Senior Statistician - Manager (1988 - 1995)
Bristol-Myers Squibb Company, New Brunswick, NJ
Responsible for statistical support to Pharmaceutical R&D (Analytical, Process Chemistry/Engineering, Pharmaceutics, and Stability). Provide statistical design and analysis for formulation/process scale up and optimization experiments and long term stability studies. Provided design of experiments to define a “Design Space" and implement Quality by Design (QbD) for compounds in development. Provided statistical input to resolve investigations as well as to respond to regulatory agencies questions. Provided support to animal Pathology/Toxicology for several years.
Manager - Nonclinical Biostatistics (1986 - 1988)
Senior Statistician (1981 - 1986)
Ayerst (Became Wyeth, then Pfizer), Rouses Pt., NY
Provided statistical support to R&D formulators, analytical chemists and process validation scientists.
Ph.D. Statistics 1981
Montana State University, Bozeman, MT
Advisor: Martin Hamilton, Ph.D.
M.S., Statistics 1976
Montana State University, Bozeman, MT
B.S., Mathematics, Psychology 1971
Bemidji State University, Bemidji, MN
Education
American Statistical Association, 1976 - Present
Pharmaceutical Quality Research Institute (PQRI)
- Container Closure Work Group, 2004 - 2015
ASTM International, 2010 – Present
International Consortium for Innovation and Quality in Pharmaceutical
Development (IQ)
– Statistics Leadership Group (2010 – 2012)
Pharmaceutical Research Manufacturing Association (PhRMA)
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CMC Statistics Expert Team, 1989 - 2009 (Chair: 2007 - 2009)
CMC Statistics Expert Team, 1989 - 2009 (Chair: 2007 - 2009) -Biostatistics Steering Committee, 1994 to 1996
Biostatistics Steering Committee, 1994 to 1996Professional Activities (Past & Present)
James Bergum - Background
