Bruce Rodda, PhD MBA

Dr. Bruce Rodda specializes in the strategic clinical and regulatory needs of the pharmaceutical and biotechnology industries from an experienced statistical perspective. He has more than 30 years of experience in the pharmaceutical industry, having directed (V.P. level) biostatistics, clinical operations, medical writing, medical development strategy, and other functions for several major pharmaceutical companies. His responsibilities over this period have included directing the statistical contributions of more than 30 NDAs and MAAs for new molecular entities in 11 therapeutic areas.

 

Bruce’s extensive multinational regulatory experience includes representing major pharmaceutical and biotechnology companies in strategic discussions with the U.S. Food and Drug Administration, presentations to several major European regulatory agencies, personal presentations to FDA advisory committees, and testifying before an FDA Commissioner’s hearing on behalf of PhRMA.

 

His areas of expertise include biostatistics, clinical trial design, and the evaluation of clinical trials. He has served on many data safety monitoring boards (DSMBs), been a member of scientific advisory boards, represented sponsors on steering committees for large clinical trials, and utilized his knowledge and experience in support of due diligence evaluations for in-licensing and acquisition activities. Bruce has served on the editorial boards of several scientific journals and has authored or co-authored approximately 70 scientific papers in applied statistics and clinical trial methodology.

 

Dr. Rodda is a Fellow and Chartered Statistician of the Royal Statistical Society (U.K.) and a Fellow of the American Statistical Association. He has been awarded a Commissioner’s Special Citation by the FDA and a Career Achievement award by the Pharmaceutical Research and Manufacturers of America. He also serves as an Adjunct Professor of Biostatistics at the University of Texas.