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#WeareBiotech
Senior Manager, Centralized Statistical Monitoring
Location
United States
Posted
15 days ago
Salary
$154.1K - $208.5K / year
Seniority
Senior
Job Description
Senior Manager, Centralized Statistical Monitoring
Amgen
• Provide statistical, technical, operational, and business leadership for CSM • 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 • Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability • Lead statistical review, interpretation, documentation, and release of CSM signals across clinical studies • Support study teams in understanding signal outputs, statistical rationale, and appropriate follow-up actions • Provide statistical judgment on unusual signal patterns, data quality concerns, operational risks, and potential study-level or site-level issues • Lead, coach, and develop statisticians and colleagues supporting CSM activities
Job Requirements
- Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 4 years of relevant experience, OR Master’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience, OR Bachelor’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 10 years of relevant experience
- 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.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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