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Centralized Statistical Monitoring, Senior Manager

United States 154104.15 - 208493.85 USD / Year · Job Posted June 09, 2026
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Job Description

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
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • discretionary annual bonus program
  • stock-based long-term incentives
  • award-winning time-off plans
  • flexible work models where possible

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