Senior Manager, Centralized Statistical Monitoring

About the role

Amgen is looking for a Senior Manager for its Centralized Statistical Monitoring (CSM) function. You will provide statistical, technical, operational and business leadership for CSM, ensuring study quality oversight is scientifically rigorous, scalable, inspection-ready and aligned with a growing clinical portfolio. The role may also support Risk-Based Quality Management (RBQM) analytical needs, including Quality Tolerance Limit (QTL) approaches.

Key responsibilities

• Serve as business owner of the CSM analysis system, signal framework and analytical workflows, and lead the CSM Statistics team
• Partner with the Head of CSM / CfDA Safety on strategy, roadmap and operating model, and advance CSM methodology within the RBQM framework
• Prioritize system enhancements, signal development, automation and RBQM analytical needs, and support governance, documentation and inspection readiness
• Define and maintain CSM standards, guidance, operating procedures and best practices
• Lead business aspects of the CSM software lifecycle, including requirements, UAT, business validation, release readiness and lifecycle management
• Provide statistical expertise on site-level analytics, outlier detection, trend analysis, anomaly detection, risk indicators, signal thresholds, comparative analytics and QTL approaches
• Develop new and enhanced CSM signals, evaluate advanced modeling, Bayesian approaches, adaptive thresholds, machine learning and AI-enabled analytics
• Lead statistical review, interpretation, documentation and release of CSM signals, and support study teams and the CSM inquiry and triage model
• Lead, coach and develop statisticians and colleagues, and build partnerships across Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality and RBQM

Required profile

• Basic: doctorate in Statistics, Biostatistics, Mathematics, Data Science or a related quantitative discipline and 4 years of relevant experience, or master's degree and 8 years, or bachelor's degree and 10 years
• Preferred: biopharmaceutical statistical experience, CSM/RBQM/QTL experience, experience owning an analytical system, and experience developing SOPs, standards and guidance
• Preferred: people management, functional or matrix leadership experience

Required skills

• Strong statistical programming and analytical skills using SAS and/or R
• Familiarity with Bayesian methods, hierarchical modeling, machine learning or advanced analytics
• Experience with R Shiny and/or business intelligence platforms preferred
• Strong communication skills in a globally dispersed, cross-cultural environment

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico), varying with skills, experience and qualifications
• Total Rewards Plan with health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and work/life balance and career development opportunities