Senior Manager, Centralized Statistical Monitoring

Amgen

Senior Manager for Centralized Statistical Monitoring at Amgen. Leading statistical, technical, operational initiatives to support clinical portfolio with rigorous oversight.

Posted 6/5/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $154,104 - $208,494 per yearWebsite

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Hard Skills & Tools

statistical analysisbiostatisticsdata sciencestatistical programmingSASRBayesian methodshierarchical modelingmachine learningadvanced analytics

Soft Skills

leadershipcoachingcommunicationpeople managementfunctional leadershipcross-functional collaborationorganizational skillsstrategic thinkingproblem-solvinginterpersonal skills