Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex early phase studies, including dose-escalation, dose-expansion, and dose-optimization design; protocol development; CRF review; SAP and analysis specification development; statistical analysis quality review; results interpretation; and CSR input and review. Provides statistical guidance to study and project teams and contributes to the evaluation and integration of emerging safety, tolerability, efficacy, pharmacokinetic/pharmacodynamic, and biomarker data to support dose escalation, dose selection, cohort expansion, and development decisions; collaborates closely with data management and statistical programming to ensure high-quality data and outputs.