Centralized Statistical Monitoring, Senior Manager

Career Category Clinical

Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas
-Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. In this vital role you will provide statistical, technical, operational, and business leadership for CSM, helping ensure that study quality oversight is scientifically rigorous, scalable, inspection-ready, and aligned with the needs of a growing clinical portfolio. The role may also support related Risk-Based Quality Management (RBQM) analytical needs, including Quality Tolerance Limit (QTL) approaches, where aligned with the CSM capability and portfolio priorities.

• Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
• Provide leadership for the CSM Statistics team and accountability for statistical deliverables supporting the CSM capability.
• Partner with the Head of CSM / CfDA Safety to shape and execute the strategy, roadmap, and operating model for CSM.
• Advance CSM methodology within the broader RBQM framework to support Quality by Design, data quality, data integrity, and study quality oversight.
• Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities.
• Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability.
• Serve as a senior point of contact for CSM-related questions, escalations, and study team support.

• Strategic and Operational Leadership Support the continued development of CSM within the broader RBQM framework. Translate portfolio needs, study team feedback, regulatory expectations, and technical considerations into clear business, statistical, and operational requirements. Define and maintain CSM standards, guidance, operating procedures, and best practices to support consistent delivery across studies.
• CSM System Ownership Lead business-related aspects of the Software Development Life Cycle for the CSM system, including requirements definition, prioritization, user acceptance testing, business validation, release readiness, and lifecycle management. Partner with Digital Technology and statistical programming colleagues to support system strategy, production implementation, testing, documentation, and continuous improvement.
• Methodology and Innovation Provide statistical expertise on CSM methodology, including site-level analytics, outlier detection, trend analysis, anomaly detection, risk indicators, signal thresholds, comparative analytics, and QTL approaches where…