Director, Central Statistical Monitoring

About the role

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.

Responsibilities

• Design and validate 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
• Implement processes to detect candidate signals across sites, subjects, and data domains (safety, efficacy, conduct, data quality)
• Characterize signals by magnitude, specificity, temporal dynamics, covariate dependence, and uncertainty; provide quantitative rationale for prioritization
• Define and apply confidence thresholds, tiering logic (e.g., high/medium/low), and criteria for automatic alerts versus human triage
• Translate statistical uncertainty and model assumptions into concrete, pragmatic next actions for operations and clinical follow-up for medical monitors
• Co-design decision trees, playbooks mapping signal types to investigative workflows, escalation paths, and CAPA triggers
• Ensure feedback loops: incorporate investigation outcomes (true/false/insufficient) to recalibrate models and to improve data collection or derivation rules
• Participate in RBQM governance meetings to align statistical approaches with study risk tolerances and regulatory expectations
• Develop and deliver training modules for clinical monitors, safety officers, DM staff, and study teams on interpreting CSM outputs and on required actions
• Provide statistical support during audits/inspections and contribute to CAPA design when monitoring uncovers systemic issues
• Act as a change agent: promote a risk-based mindset, help define governance criteria, and support SOP updates
• Define KPIs for CSM effectiveness: time-to-investigation, confirmation rate, and downstream corrective actions
• Monitor performance dashboards, conduct periodic reviews, and implement improvements to models, thresholds, and communication templates

Requirements

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 statisticsRBQM/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

Qualifications

N/A

Skills

N/A

Benefits

N/A

Pay

$187,100.00 - $247,100.00 annually

Schedule

N/A