BergumSTATS, LLC
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Statistical Consulting
BergumSTATS provides statistical consulting to scientists in both Research/Development and Manufacturing. With over 30 years of experience as a non-clinical statistician in the pharmaceutical industry, BergumSTATS has developed excellent consulting skills to help scientists apply appropriate statistical methods as well as the ability to communicate statistical concepts and results. Our primary experience is with scientists that are involved with preparing the Chemistry, Manufacturing, and Control (CMC) section of drug submissions for small molecules. Areas of expertise include design/analysis of experiments applied to drug product formulation and drug synthesis, development/validation of analytical methods, design (matrixing/bracketing)/analysis of stability studies, developing sampling/statistically based criteria for process validation (ASTM standards E2709/E2810 & "Large N"), providing designs/analysis for Quality by Design (QbD) development strategies, and developing product specifications.
