• Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department • Support the RBQM: providing statistical design, interpretation, and governance for monitoring activities • Accountable for development, validation, and operationalization of statistical monitoring indicators and models • Acts as the CSM statistician interfacing with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations (GCO), quality/GCP, data management • Defines statistical thresholds, signal characterization methods, and recommended investigative workflows • Escalates safety or major data integrity concerns to medical monitors, safety leadership, and quality • Develop and maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tools • Validate models and algorithms: assumptions, diagnostics, false positive/negative rates, sensitivity analyses, and reproducibility • Implement processes to detect candidate signals across sites, subjects, and data domains • Develop and deliver training modules for clinical monitors