Director, Centralized Statistical Monitoring
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Job Description
Director for Centralized Statistical Monitoring at Amgen overseeing CSM analysis and leadership roles. Focusing on innovative methodologies and ensuring compliance with regulatory standards in clinical trials.
Responsibilities:
- Provide strategic, statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM).
- Accountable for the CSM analysis system, signal framework, statistical methodology, team leadership, cross-functional delivery, and continued evolution of CSM as part of Amgen’s broader Risk-Based Quality Management (RBQM).
- Lead CSM capability development across a growing clinical portfolio, ensuring that CSM remains scientifically rigorous, scalable, inspection-ready, and aligned with portfolio, regulatory, study team, and business needs.
- Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
- Lead the strategy, roadmap, operating model, and continued evolution of the CSM capability in partnership with the Head of CSM / CfDA Safety and cross-functional stakeholders.
- Provide leadership and accountability for the CSM Statistics team and statistical deliverables supporting the CSM capability.
- Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical 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.
- Lead governance, documentation, inspection readiness, lifecycle management, and long-term sustainability of the CSM capability.
- Serve as a senior point of accountability for CSM-related questions, escalations, study team support, and cross-functional alignment.
- Lead, coach, and develop CSM statisticians and supporting resources. Direct line management responsibilities may be in scope depending on the final operating model.
Requirements:
- Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience OR Master's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 12 years of relevant experience
- Significant statistical experience in the biopharmaceutical industry, including clinical development and clinical trial statistical oversight.
- Experience with Centralized Statistical Monitoring, RBQM, QTLs, Quality by Design, data integrity, 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, product owner, capability lead, or functional owner for an analytical, statistical, or clinical system, including SDLC activities such as requirements, UAT, business validation, release readiness, documentation, and lifecycle management.
- Strong statistical programming and analytical skills using SAS and/or R; Python experience a plus, with experience working with clinical trial, operational, EDC, metadata, or external data sources.
- Familiarity with Bayesian methods, hierarchical modeling, machine learning, advanced analytics, R Shiny, or business intelligence platforms.
- People management, functional leadership, coaching, or matrix leadership experience, including leading cross-functional initiatives.
- Strong communication skills, global collaboration skills, and understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, data integrity, 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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