[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.