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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 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.

Cross‑functional interpretation and communication:

+ 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.

Operationalization and decision logic:

+ 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.

Training, governance, and stakeholder enablement:

+ 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.

Performance monitoring and continuous improvement:

+ 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.

Supervisory Responsibilities:

+ Yes

Required background:

+ 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

**Computer Skills:** Microsoft Office, PowerBI

**Other Qualifications:** N/A

**Travel:** Occasionally travelling is expected

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.