John Shen

Biostatician

John is a 20-year experienced medical biostatician in medical device, pharmaceutical, and digital health technologies. John specializes in clinical trial design, strategy, analysis, and reporting to support early product feasibility, product approval and post-marketing requirements for payer acceptance around the world. He has experience across many different therapeutic areas and managed a global team of experienced biostatisticians and data managers in a global medical research organization for medical devices and IVDs. He was a member of China NMPA guidance development and has been a frequent speaker in the clinical trial and regulatory conferences. He has been a principal consultant to Medtronic managing Atrial Fibrillation clinical trial study design, analysis reporting at FDA panel meetings. He has held statistical positions in global CROs, such as Parexel, 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.