Director, Central Statistical Monitoring

General Description Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department to support the RBQM. Provide 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 compliant. Essential Functions of the Job Design and validation of monitoring analytics; develop and maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tools 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 candidate signals across sites, subjects, and data domains; characterize signals by magnitude, specificity, temporal dynamics, covariate dependence, and uncertainty. Define and apply confidence thresholds, tiering logic (e.g., high/medium/low), and criteria for automatic alerts versus human triage. Cross‑functional interpretation and communication: produce tiered deliverables including one‑line headlines for executives, concise operational briefs for GCO, and detailed technical appendices for analytic teams. Operationalization and decision logic: co‑design decision trees, playbooks mapping signal types to investigative workflows, escalation paths, and CAPA triggers; incorporate investigation outcomes to recalibrate models and improve data collection or derivation rules. Participate in RBQM governance meetings to align statistical approaches with study risk tolerances and regulatory expectations. Training, governance, and stakeholder enablement: develop and deliver training modules for clinical monitors, safety officers, DM staff, and study teams; provide statistical support during audits/inspections and contribute to CAPA design when monitoring uncovers systemic issues. Performance monitoring and continuous improvement: define KPIs for CSM effectiveness; monitor performance dashboards, conduct periodic reviews, and implement improvements to models, thresholds, and communication templates. Supervisory Responsibilities: Yes Required Background Master’s degree with 7 years’ experience or Ph.D. with 5 years’ experience in biostatistics, statistics, or related quantitative field. Demonstrated experience in clinical trial statistics, RBQM/CSM, and signal triage. Strong stakeholder management and communication skills. Experience with model lifecycle management, validation, and documentation for audits/inspections. Computer Skills Microsoft Office, PowerBI Other Qualifications N/A Travel Occasionally travelling is expected. Global Competencies Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self‑Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results‑Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range $187,100.00 - $247,100.00 annually EEO Statement We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact View email address on click.appcast.io. #J-18808-Ljbffr