Sanofi Expert Witnesses

Landenberg, Pennsylvania

Statistics, Medical Devices - biostatistics, FDA, Pharmaceutical Statistics, Sanofi, Edwards, Gilead, AI/ML expert, machine learning, clinical trial, Medical Device, Vaccine, Group Sequential Design, Bayesian Adaptive Design, Statistical Review of Evidence, Oncology, Epidemiological, Regulatory Submissions, Survival Analysis, Statistical Expert Witness, RWE

Lei Li, PhD, is a biostatistician and former FDA CDRH statistical reviewer with extensive experience in regulatory statistics, Real-World Evidence (RWE), medical device submissions, and pharmaceutical development. At FDA, Dr. Li evaluated statistical components of 510(k) and PMA submissions, assessed safety and effectiveness evidence for medical devices, reviewed RWE and post-market studies, and advised on complex statistical issues for regulatory decision-making. His FDA work included evaluation of study design adequacy, endpoint justification, sample-size rationale, bias and confounding, missing data robustness, and interpretation of clinical performance metrics under regulatory standards. In industry, Dr. Li served as Statistical Project Leader at Sanofi and Principal Biostatistician at Edwards Lifesciences, supporting global clinical and regulatory programs across multiple therapeutic areas, including rare diseases, inflammatory diseases, vaccines, oncology, and cardiovascular ...