Leads or directly contributes to protocol development, case report form review, statistical analysis plans and analysis specifications, statistical programming specifications, modeling and simulation, statistical analyses, results interpretation, clinical study reports, regulatory documents, and scientific communications. Provides statistical strategy and consultation for assigned EDO studies and projects, including innovative study design, endpoint selection, dose escalation, dose and schedule optimization, cohort expansion, biomarkers, proof-of-concept assessment, and program advancement or transition decisions.