Strategic Statistical Consulting LLC specializes in supporting the strategic clinical and regulatory needs of pharmaceutical and biotechnology industries from an experienced statistical perspective. We provide a highly experienced statistical resource to clients in designing and evaluating clinical protocols, clinical study reports, statistical analysis plans, regulatory strategies, and regulatory submissions. Our broad experience in all aspects of clinical trials can also be an important element in due diligence review of clinical trial information for in-licensing and M&A decision making. Strategic Statistical Consulting LLC is also experienced in providing sponsors and legal firms with technical expertise and expert testimony related to litigation.
Bruce E. Rodda, Ph.D., M.B.A. is the principal of Strategic Statistical Consulting LLC. He has more than 30 years of experience in the pharmaceutical industry, having directed (V.P. level) biostatistics, clinical operations, medical development strategy, medical writing, and other functions for several major pharmaceutical companies. Areas of expertise include biostatistics and clinical trial design and methodology. He is the author of approximately 70 scientific publications and is a Fellow of the American Statistical Association, a Chartered Statistician of the Royal Statistical Society, and is the recipient of a Commissioner’s Special Citation from the FDA and a Career Achievement Award from PhRMA. Dr. Rodda is currently Adjunct Professor of Biostatistics at The University of Texas.