Ph.D. Biostatistician, Clinical Trials Expert

Specialties & Experience of this Expert Witness

Additional Information

Dr. Rodda is an experienced biostatistician specializing in the clinical and regulatory objectives of pharmaceutical and biotechnology companies. He has held senior positions in research and development at several major pharmaceutical companies. In those positions his responsibilities included directing the strategy, design, implementation, evaluation, and reporting of all phases of multinational clinical development programs. These positions included directing (V.P. level) biostatistics, data management, clinical operations, medical development strategy, protocol review, medical writing, project management, and scientific systems. His organizations have been instrumental in the approval of more than 30 new medical entities in 11 therapeutic areas, both in the U.S. and abroad. Following a career as an executive in the pharmaceutical industry, he established Strategic Statistical Consulting LLC and has provided statistical consulting to approximately 70 firms focussing on clinical trials in a variety of therapeutic areas. He has participated in more than 150 meetings with FDA personnel, made presentations to FDA advisory committees, and participated in meetings with nine foreign regulatory agencies. He has also served on several data safety monitoring boards, participated in due diligence for mergers and acquisitions, and testified as an expert witness on several occasions. He is skilled at critical evaluation of clinical trials, the methodology used for their design and analysis, and the inferences/conclusions made from them. Dr. Rodda is an accredited professional statistician (PStat) of the American Statistical Association, an elected Fellow of the American Statistical Association, the recipient of a Commissioner’s Special Citation from the FDA, and a recipient of a Career Achievement Award from PhRMA. He has held several academic appointments and currently serves as Adjunct Professor of Biostatistics at The University of Texas where he has taught courses in biostatistics and clinical trial design and methodology.