• Lead statistical design for clinical studies, including estimands, endpoint selection, sample size, and modeling approaches. • Author or oversee SAPs and associated analysis specifications. • Guide quantitative strategy across exploratory, interim, and confirmatory study phases. • Lead exposure-efficacy and exposure-safety analyses using clinical exposure metrics. • Apply statistical modeling approaches in R or Python. • Develop simulation-based scenarios to support dose selection and benefit-risk assessments. • Oversee blinded exploratory analyses using ARR and other metadata-driven layers. • Guide Statistical Data Scientists in the implementation, visualization, and reproducible execution of exploratory models. • Ensure quantitative analyses are implemented within reproducible, metadata-driven frameworks. • Partner with Statistical Data Scientists and programming teams to translate quantitative intent into executable specifications. • Support validation, traceability, and audit readiness of all quantitative workflows. • Provide quantitative interpretation for study teams, governance discussions, and regulatory documents. • Review CSRs and contribute to regulatory responses involving quantitative rationale. • Mentor Statistical Data Scientists and Statistical Programmers on modeling, statistical methodology and interpretation.