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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.
Job Responsibility
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
Requirements
Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 4 years of relevant experience
Master's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience
Bachelor's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 10 years of relevant experience
Nice to have
Statistical experience in the biopharmaceutical industry including clinical development
Experience with CSM, RBQM, QTLs, Quality by Design, or clinical trial quality oversight
Experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment
Experience serving as a business owner or functional owner for an analytical system, including business-related aspects of the Software Development Life Cycle
Strong statistical programming and analytical skills using SAS and/or R
Familiarity with Bayesian methods, hierarchical modeling, machine learning, or advanced analytics
Experience with interactive visualization tools such as R Shiny and/or business intelligence platforms
People management, functional leadership, coaching, or matrix leadership experience, including leading cross-functional initiatives
Experience developing SOPs, standards, guidance, or operating procedures
Strong communication skills and ability to work effectively in a globally dispersed, cross-cultural environment
Understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, and centralized monitoring
What we offer
Retirement and Savings Plan with generous company contributions