Designs statistical analysis plans for Phase I, II, and III clinical trials. Performs statistical analysis of clinical trial data using SAS or R software. Prepares statistical outputs including tables, figures, and listings (TFLs). Reviews and validates clinical data for statistical consistency and accuracy. Supports sample size calculations and randomization schedules for trials. Contributes statistical sections to clinical study reports and regulatory submissions. Collaborates with data management teams on database lock and data review. Provides statistical input for protocol design and study feasibility assessments. Develops statistical specifications for programming and validation activities. Reviews and approves SAS programs used for regulatory submission outputs. Supports adaptive trial design and interim analysis planning. Provides biostatistical training and guidance to junior statisticians. Stays updated with FDA statistical guidelines, ICH E9 R1, and estimand framework.