Jason Schroeder, PhD is a biostatistician with 20 years of industry and FDA experience in a variety of therapeutic areas. Dr. Schroeder worked for FDA from 2004-2018, serving as a statistician and team leader in CDRH (2004-2017), leading statisticians reviewing clinical trials for respiratory, gynecological, urological, gastrointestinal, and renal therapeutic devices. He also served as an Associate Director in CDER’s Oncology Division of Biometrics 5 (2017-2018) supervising teams of statisticians reviewing the design and analysis of clinical trials for products treating various cancers. After leaving FDA, he held leadership roles at Myovant Sciences, Amgen’s Center for Design and Analysis, and Olema Pharmaceuticals. Dr. Schroeder now works with pharmaceutical and device companies to help design, conduct, and evaluate clinical trials, bridging the gap between statisticians, clinicians, and other key collaborators. His services include clinical trial design, protocol development, sample size calculations, statistical analysis plans, CSR and CRF contribution, data monitoring committee services, and development of regulatory strategies for FDA submissions and advisory panels.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
