Biohemistry – Michigan State University 

M.S. Statistics – Colorodo State University


Expertise:  CMC nonclinical and pre-clinical statistics. Process and analytical method development, optimization, validation, and comparability. Experimental design and analysis. Biosimilarity, Bio- & immuno-assays, Pharmaceutical Stability, dissolution, content uniformity, Compendial methods, QbD/Design space identification, measurement uncertainty, sample size determination, computer modeling and simulation, predictive analysis and risk assessment, Bayesian methods. Fluent in SAS, R, JMP, BUGS.


  • Medical Device Diagnostics R&D and biometrics (17 years).

  • Pharmaceutical Drug Development, non-clinical and pre-clinical statistics (16 years)

  • CMC Statistical Consultant (2 years)

Other:  Adjunct Instructor, University of Illinois College of Pharmacy, Biopharmaceutical Sciences. Member, USP Statistics Expert Committee, American Statistical Association, AAPS.

Email  David LeBlond CV