Associate Director, Statistical Monitoring

General Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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.

• Design and validate 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.
• 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 (high/medium/low), and criteria for automatic alerts versus human triage.
• Produce tiered deliverables: one‑line headline for executives, concise operational briefs for GCO, and detailed technical appendices for analytic teams; 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 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.
• Develop and deliver training modules for clinical monitors, safety officers, DM staff, and study teams on interpreting CSM outputs and 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, monitor performance dashboards, conduct periodic reviews, and implement improvements to models, thresholds, and communication templates.
• Supervisory Responsibilities:
  
  involve oversight of team members where applicable.

Master’s degree with 6 years’ experience or Ph.D. with 4 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.

Microsoft Office, PowerBI.

None.

Occasionally travelling is expected.

Salary Range: $ - $ annually.

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job‑related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. Non‑Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.

All Company employees have the opportunity to own shares of BeOne Medicines…