Senior Manager of Statistical Monitoring

Job Summary

Providing statistical, technical, operational, and business leadership, the full-time remote Senior Manager of Statistical Monitoring will oversee Amgen's Centralized Statistical Monitoring (CSM) analysis system, ensuring study quality oversight and advancing CSM methodology within a Risk-Based Quality Management framework.

Key Responsibilities

• Lead business aspects of the Software Development Life Cycle for the CSM system, including requirements definition and lifecycle management
• Provide statistical expertise on CSM methodology, including site-level analytics and signal development
• Support study teams in understanding signal outputs and ensure quality and traceability of CSM signals across clinical studies

Required Qualifications

• Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline with 4 years of relevant experience, OR
• Master's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline with 8 years of relevant experience, OR
• Bachelor's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline with 10 years of relevant experience
• Statistical experience in the biopharmaceutical industry, including clinical development
• Experience with CSM, RBQM, QTLs, or clinical trial quality oversight