Mark Chang, PhD, applies his 20 years of experience as a statistician at both biopharmaceutical firms and CROs to excel in his role as a strategic statistical consultant. He is experienced with NDA submissions and working collaboratively with regulatory agencies throughout the clinical trial and submission process. Dr. Chang is also an adaptive design expert, having published 8 books on biostatistics and adaptive clinical trial designs.
Dr. Chang is a fellow of the American Statistical Association and an adjunct professor of Biostatistics at Boston University. He is a co-founder of the International Society for Biopharmaceutical Statistics, co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, and a member of the Multiregional Clinical Trial (MRCT) Expert Group.
Dr. Chang received his Ph.D. in Civil Engineering and his Masters of Science in Biostatistics at the University of Massachusetts in Amherst, MA. He also received his Masters of Science and Bachelors of Science degrees at Hohai University in Nanjing, China.