Dr. Jim MacDougall, a biostatistician for 21 years, joined PROMETRIKA as a senior biostatistical consultant in early 2014. Dr. MacDougall has extensive experience in all phases of clinical research, including multiple regulatory submissions.
As a departmental head and lead statistician, Dr. MacDougall has been responsible for the scientific and managerial success of complete clinical programs (phases 1 through 3 and submissions) in the therapeutic areas of gastroenterology, endocrinology, medical imaging, infectious disease, neurology, and women’s health. He has also been the lead statistician in many phase 1-2 oncology trials. Dr. MacDougall has been involved with many innovative statistical techniques for clinical trials, including a novel Bayesian approach using historical data to model and impute long-term disease progression.
Dr. MacDougall has prepared for, and presented at, FDA Advisory Committee meetings, and has presented at numerous scientific biopharmaceutical industry conferences. He is the lead or co author of many journal articles and author of a chapter in “Dose Finding in Drug Development”, published in 2006. Dr. MacDougall has been an active member of the Boston Chapter of the ASA for over 10 years.
Prior to joining PROMETRIKA, Dr. MacDougall served as Vice President of Biometrics at Ironwood Pharmaceuticals, which he joined in 2006. Prior to joining Ironwood, Dr. MacDougall held the position of Director of Biostatistics at Genzyme, Idenix, and Bristol-Myers Squibb Medical Imaging. Dr. MacDougall received his Doctor of Philosophy degree in Biostatistics from the University of North Carolina at Chapel Hill in 1999.