Journal of Bioequivalence & Bioavailability

Mitchell Kotler

Biography

Mitchell Kotler is an experienced Director of Biostatistics in the healthcare industry with full managerial responsibilities for recruitment, performance review and other HR functions. He also has full Biostatistics support of regulatory submissions (FDA and other agencies) - eCTD modules, CDISC (SDTM and ADaM) conversions, OTC switch and bioequivalence routes and supported proof-of-concept / pilot, claims, and pivotal studies; Therapeutic areas include smoking cessation, pain relief, allergy, weight control, and oral care. Expertise in process development / improvement and project milestone tracking. Statistical methodology in linear models, nonparametric statistics, extact testing, survival analysis, proportional hazards, TOST (for PK/BE), imputation, sensitivity analysis, logistic analysis of categorical data.

Research Interest

Clinical Trials Regulatory Affairs Clinical Development