Veristat, a full service CRO, has strengthened its statistical consulting and adaptive design expertise with the appointment of Mark Chang, Ph.D., to the newly created position of senior vice president of Strategic Statistical Consulting. Dr. Chang will help clients evaluate and implement strategic, operational and technical efficiencies to advance products through the clinical trial and regulatory submission process.
“Veristat is thrilled to welcome such an esteemed clinical research and statistical expert to Veristat,” stated John Balser, Ph.D., president of Veristat. “Mark will provide Veristat’s clients with the intellectual leadership to optimize their clinical development plans, trial designs and regulatory submission strategies. His experience with designing and implementing both simple and complex adaptive design trials is unmatched in the industry.”
Dr. Chang joins Veristat with more than 20 years of experience as a statistician at both biopharmaceutical firms and CROs, including AMAG Pharmaceuticals, Millenium/Takeda Pharmaceuticals, PAREXEL and MTRA. He is experienced with NDA submissions and working collaboratively with the regulatory agencies throughout the clinical trial and submission process. Dr. Chang is also an adaptive design expert, having authored and co-authored dozens of books and peer- reviewed journal publications on adaptive design methodologies and implementation in clinical trials.
In addition, 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. Throughout his career, he has frequently held advisory posts for numerous industry committees and served as an associate editor for many peer-reviewed publications. He has given over 50 lectures, short courses, and invited speeches at national and international conferences and has been invited twice to present at the FDA.