[Remote] Director, Biostatistician (Evergreen)

Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a rapidly growing company focused on fighting cancer, seeking a Director of Biostatistics to lead the Central Statistical Monitoring team. The role involves developing statistical monitoring indicators, collaborating with clinical teams, and ensuring data integrity throughout clinical trials.

Responsibilities

• 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
• 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
• 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
• 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 (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

Skills

• 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 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

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Company Overview

• BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, US, with a workforce of 10001+ employees. Its website is https://www.beonemedicines.com.

Company H1B Sponsorship

• BeOne Medicines has a track record of offering H1B sponsorships, with 20 in 2025. Please note that this does not guarantee sponsorship for this specific role.

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