Job Overview
Location
Remote (US)
Job Type
Full-time
Category
Data Science
Date Posted
April 10, 2026
Full Job Description
đź“‹ Description
- • Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department to support risk-based quality management (RBQM) by providing statistical design, interpretation, and governance for monitoring activities that protect subject safety, ensure data integrity, and support trial reliability across BeiGene’s clinical development portfolios.
- • Develop and validate statistical risk indicators (KRIs), anomaly detection methods, and monitoring tools; partner with study teams to specify data derivations and analytic data snapshots required by CSM algorithms; validate models and algorithms for 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; define and apply confidence thresholds, tiering logic, and criteria for automatic alerts versus human triage.
- • Produce tiered deliverables for executives, clinical operations, and analytic teams; translate statistical uncertainty into concrete next actions for operations and clinical follow-up; co-design decision trees, playbooks, escalation paths, and CAPA triggers; 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, data management staff, and study teams on interpreting CSM outputs; provide statistical support during audits/inspections; act as a change agent to promote a risk-based mindset and support SOP updates.
- • Define KPIs for CSM effectiveness (time-to-investigation, confirmation rate, downstream corrective actions); monitor performance dashboards, conduct periodic reviews, and implement improvements to models, thresholds, and communication templates.
- • Supervise the CSM team; collaborate with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations, quality/GCP, and data management to ensure signals are interpretable, actionable, and compliant.
🎯 Requirements
- • Master’s degree with 6 years of experience or Ph.D. with 4 years of experience in biostatistics/statistics or a 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.
- • Proficiency in Microsoft Office and PowerBI.
🏖️ Benefits
- • Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
- • Opportunity to own shares of BeiGene Medicines Ltd. stock through discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
- • Eligibility to participate in the annual bonus plan (for non-commercial roles).
- • Commitment to fair and equitable compensation practices with salary range of $162,600.00 - $212,600.00 annually.
- • Support for reasonable accommodations under Section 503 of the Rehabilitation Act, VEVRAA, ADA, and other applicable laws.
Skills & Technologies
About BeiGene, Ltd.
BeiGene is a global biotechnology company discovering, developing, manufacturing and commercializing innovative oncology medicines. Its broad pipeline includes more than 50 clinical-stage molecules, spanning targeted therapy, immuno-oncology and combination regimens. Core products are BTK inhibitor BRUKINSA, PD-1 antibody tislelizumab and PARP inhibitor pamiparib, marketed worldwide through internal teams and strategic alliances. BeiGene operates integrated research campuses in Beijing and Cambridge, MA, a manufacturing facility in Suzhou and offices across North America, Europe and Asia-Pacific, serving patients in more than 45 countries.
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