John Shen

John has extensive experience in the strategy, design, analysis, and reporting of clinical trials and programs to support early product feasibility, product approval and post-marketing requirements around the world. He has worked over 18 years in pharmaceutical, medical device and IVD industries with strong and diverse therapeutic background. He managed a global team of experienced consultants to support global medical product development. He participated in NMPA guidance development and has been a frequent speaker in the clinical trial and regulatory conferences. He was a principal consultant at Medtronic managing the Atrial Fibrillation clinical trial including study design, analysis reporting and panel meeting with FDA. He also held statistical positions in other global CROs, such as Parexel and PPD, and Indiana University. He has authored and coauthored >40 peer-reviewed statistical and medical publications and numerous presentations and regulatory submissions. John earned his Master of Science degree in statistics from the University of Georgia and medical degrees (M.D., M.S.) from Capital Medical University and Hebei Medical University in China.