Regulatory Submissions Expert Witnesses
Regulatory submissions expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on regulatory submissions. The regulatory submissions expert witness listings on this page are typically from fields/areas of expertise such as: Medical Devices and Statistics.
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Lei Li
PhD Biostatistician & FDA Clinical Trial Expert
LunarAI LLC
Landenberg, Pennsylvania
Statistics, Medical Devices
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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, statistical expert consultant, and former FDA/CDRH statistical reviewer with extensive experience in regulatory statistics, real-world evidence (RWE), medical device submissions, pharmaceutical development, clinical trials, and quantitative model evaluation. He is currently supporting two active expert consulting matters involving statistical evidence review, regulatory and clinical data interpretation, assessment of quantitative methods, and evaluation of model assumptions, uncertainty, and data reliability.
At FDA/CDRH, Dr. Li evaluated statistical components of 510(k), PMA, and other medical device submissions; assessed safety and effectiveness evidence; 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...
