Job Description
General Description: Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department to support the RBQM: providing statistical design, interpretation, and governance for monitoring activities that protect subject safety, ensure data integrity, and support trial reliability across BeOne's clinical development portfolios. Accountable for development, validation, and operationalization of statistical monitoring indicators and models across one or multiple studies/programs. Acts as the CSM statistician interfacing with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations (GCO), quality/GCP, data management to ensure signals are interpretable, actionable, and compliance. RBQM statistical playbook; signal triage decision trees; standardized signal report templates; training materials for cross-functional stakeholders; performance dashboards tracking signal investigation metrics. In collaboration with governance bodies, defines statistical thresholds, signal characterization methods, and recommended investigative workflows. Escalates safety or major data integrity concerns to medical monitors, safety leadership, and quality with rationale. Essential Functions of the Job: Design and validation of monitoring analytics Develop and maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tool appropriate for study purpose and data flows. Partner with study team to specify data derivations, edit checks, and analytic data snapshots required by CSM algorithms. Validate models and algorithms: assumptions, diagnostics, false positive/negative rates, sensitivity analyses, and reproducibility. Signal detection, characterization, and prioritization: Implement processes to detect can