Biostatistics Expert Witnesses

Biostatistics shapes the evidence in many high-value disputes because clinical, epidemiological, and health data rarely speak for themselves. Pharmaceutical and device companies, licensors, and investors litigate over whether clinical trial results were properly designed, analyzed, and disclosed, while patent disputes in the life sciences frequently turn on statistical evidence of efficacy, synergy, or unexpected results. Health plans and government payers rely on statistical sampling to extrapolate overpayment demands that providers then challenge, and employers face statistical analyses of compensation and promotion data in discrimination cases. In each setting, the central question is whether the study design, data, and analytical methods support the conclusions a party has drawn from them.

A biostatistics expert answers that question by examining how data were collected, analyzed, and interpreted. The expert can evaluate randomization, power and sample size, endpoints, missing data, multiple comparisons, and survival analysis in clinical trials, and assess confounding, bias, and causal inference in observational studies. In payment disputes, the analysis tests whether sampling frames, sample sizes, and extrapolation methods meet accepted statistical standards, while employment matters may involve regression and survival models of workforce outcomes. These opinions help counsel support or rebut efficacy and safety claims, challenge or defend extrapolated damages, and expose analyses that rely on post hoc subgroups, inappropriate models, or selective reporting.

Biostatistics disputes demand experts whose methodological depth matches the study type and analytical question at issue. Round Table Group works with biostatisticians who have worked with the National Institutes of Health, the Royal Statistical Society, and the FDA, including researchers who have published extensively on clinical trials, meta-analysis, diagnostic test evaluation, causal inference, and survival analysis, one of whom received a major award recognizing outstanding statisticians under 40. The network also includes epidemiologists and health economists, specialists in claim overpayment estimation and legal statistics, and biostatisticians who have testified on patent issues, meta-analyses of cardiovascular stent studies, clinical trial results, and study design. With more than 75,000 expert searches completed for litigators, we can help you identify the right biostatistics expert by calling us at (202) 908-4500.