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 maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tools; validate models and algorithms including assumptions, diagnostics, false positive/negative rates, sensitivity analyses, and reproducibility.
- • Implement processes to detect, characterize, and prioritize signals across safety, efficacy, conduct, and data quality domains; define 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 actionable next steps for operations and clinical follow-up.
- • Co-design decision trees, playbooks, and escalation paths; ensure feedback loops from investigation outcomes to recalibrate models and improve data collection.
- • Develop and deliver training for clinical monitors, safety officers, and data management staff; support audits/inspections and contribute to CAPA design.
- • Define KPIs for CSM effectiveness such as time-to-investigation and confirmation rate; monitor performance dashboards and implement continuous improvements.
- • Supervise the CSM team and collaborate with cross-functional stakeholders including clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations, quality/GCP, and data management.
- • Promote a risk-based mindset, support SOP updates, and act as a change agent in advancing RBQM governance.
🎯 Requirements
- • Master’s degree with 7 years of experience or Ph.D. with 5 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 and 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 programs.
- • Opportunity to participate in the annual bonus plan.
- • Eligibility for discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
- • Support for professional development and continuous learning.
- • Commitment to fair and equitable compensation practices.
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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