James Bergum

  PhotoAfter over 30 years as a statistician in the pharmaceutical industry, Jim retired in 2012 and started BergumSTATS, a statistical consulting company specializing in statistics related to Chemistry, Manufacturing, and Control (CMC) issues. His current interests are statistical methodologies that can be applied to product development, process validation, and manufacturing. After receiving a Ph.D. in Statistics from Montana State University, Jim worked in nonclinical biostatistics for Wyeth from 1981 to 1988 and Bristol Myers Squibb from 1981 to 2012. His primary job responsibility was to provide statistical support to Research & Development including design and analyses of experiments, analytical assay development and method validation, process validation, stability, drug safety evaluation, and teaching short courses to scientists. He developed a statistical method that resulted in two ASTM methods (ASTM E2709 referenced in the FDA guidance for Process Validation & E2810) that can be used to evaluate development, process validation, or release data.