Job 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
Apply Now
Apply Now