Biostatistics Expert Witnesses

Scottsdale, Arizona

Statistics - Statistician, Data Analytics, Criminal Justice Data, Police Data, Neighborhood Association Data, Gun Death Data, Public Health Data, Opioid Overdose Data, Census Data, Medical Data, Biostatistics, Proportions, Discrimination, Construction defect data

Ph.D. in public policy and econometrics from the University of Maryland in College Park. Holder of the PStat certification from the American Statistical Association, their highest designation, indicating professional statistician. Former Fulbright professor. Statistician with extensive experience in biostatistics, social sciences and public health sectors. This includes, but is not limited to, criminal justice data experience regarding police stops, traffic stops, large jail data, prosecution data, and risk assessment tool validation. Expertise with Violent Death Reporting System data including gun death data, drug overdose death data, accidental death data, and violence prevention. Homelessness data experience. Experience in biostatistics research methodology for various medical topics including brain tumors, effectiveness of neurological medical devices, hospital trauma department research, and gynecological diagnoses such as endometriosis and pudendal nerve damage. Litig...

Laguna Beach, California

Epidemiology, Public Health - Biostatistics, Statistics, Causality, Study Design, Model Evaluation, Malpractice, Toxic Torts, Patent Disputes, Covid-19, Statistical Models, Data Analysis, Covid-19

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, 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...

Spicewood, Texas

Statistics, Pharmaceutical Research - Biostatistics, Clinical Trials, Statistical Analysis, Design of Clinical Trials, Expert Reports, Clinical Reports, Regulatory Review, Due Diligence for M & A, Clinical Literature, Expert Testimony, Protocol Evaluation, Evaluation of Clinical Trials

Dr. Rodda is an experienced biostatistician specializing in the clinical and regulatory objectives of pharmaceutical and biotechnology companies. He has held senior positions in research and development at several major pharmaceutical companies. In those positions his responsibilities included directing the strategy, design, implementation, evaluation, and reporting of all phases of multinational clinical development programs. These positions included directing (V.P. level) biostatistics, data management, clinical operations, medical development strategy, protocol review, medical writing, project management, and scientific systems. His organizations have been instrumental in the approval of more than 30 new medical entities in 11 therapeutic areas, both in the U.S. and abroad. Following a career as an executive in the pharmaceutical industry, he established Strategic Statistical Consulting LLC and has provided statistical consulting to approximately 70 firms focussing on clinic...