BergumSTATS, LLC
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Statistical Consulting
James Bergum, PhD
President
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About BergumSTATS, LLC
BergumSTATS is a statistical consulting business started by James Bergum in 2012 after over 30 years as a "Nonclinical" statistician in the pharmaceutical industry. BergumSTATS areas of expertise include design and analysis of experiments applied to formulation, drug synthesis, analytical method development, and stability studies as well as "design space" , Quality by Design, and developing methods to evaluate process validation data. Jim developed a method (CuDAL) for evaluating data (ex content uniformity, dissolution) against established standards (ex USP) that resulted in ASTM standards E2709 and E2810. The method is referenced in the FDA guidance on process validation.
James has experience with internal company investigations, responses to regulatory agencies, pre-approval inspection, and meetings with regulatory agencies. He has also gained a broad overview of the statistical methodology used throughout industry from memberships in professional groups as well as presentations at professional meetings.
