Director, Biostatistician – Evergreen

🕒 January 15

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department • Support the RBQM: providing statistical design, interpretation, and governance for monitoring activities • Accountable for development, validation, and operationalization of statistical monitoring indicators and models • Acts as the CSM statistician interfacing with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations (GCO), quality/GCP, data management • Defines statistical thresholds, signal characterization methods, and recommended investigative workflows • Escalates safety or major data integrity concerns to medical monitors, safety leadership, and quality • Develop and maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tools • 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 • Develop and deliver training modules for clinical monitors

🎯 Requirements

• 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

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