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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

biostatisticsstatisticsstatistical designstatistical monitoringmodel validationanomaly detectionsignal characterizationsensitivity analysisstatistical risk indicatorsclinical trial statistics

Soft Skills

stakeholder managementcommunicationleadership

Certifications

Master's degreePh.D