Wei-chen Chen is a Mathematical Statistician with 13 years of experience applying computational statistics to regulatory review of medical devices, including cardiovascular, ENT, orthopedic, neurostimulation, and certain in vitro diagnostics. Based at FDA CDRH after an ORISE fellowship at CBER, he evaluates Pre-Subs, IDEs, 510(k)s, and PMAs, translating complex statistical evidence into actionable regulatory decisions. His background includes postdoctoral research at the University of Tennessee and Oak Ridge National Laboratory, reflecting strong ties to both applied and computational research. Holding a PhD in Statistics from Iowa State University, he brings deep methodological rigor to practical regulatory challenges and a knack for bridging advanced analytics with real-world device safety and efficacy assessments.
13 years of coding experience
3 years of employment as a software developer
Doctor of Philosophy - PhD, Statistics, Doctor of Philosophy - PhD, Statistics at Iowa State University
Contributions:63 commits, 51 pushes in 8 years 8 months
Find and Hire Top DevelopersWe’ve analyzed the programming source code of over 60 million software developers on GitHub and scored them by 50,000 skills. Sign-up on Prog,AI to search for software developers.