BeOne Medicines · 2 days ago
Director, Biostatistician (Evergreen)
United States
Full-time
Remote
Lead/Staff, Director/Executive
$187K/yr - $247K/yr
5+ years expBeOne 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.
Pharmaceuticals
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
Qualification
Required
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
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase