Centralized Statistical Monitoring, Senior Manager

Amgen Inc.

Job Overview

Location

United States - Remote

Job Type

Full-time

Full Job Description

📋 Description

• Lead statistical, technical, operational, and business strategy for Amgen’s Centralized Statistical Monitoring (CSM) capability to ensure scientifically rigorous, scalable, and inspection-ready study quality oversight.
• Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows, including end-to-end ownership of requirements, prioritization, user acceptance testing, and release readiness.
• Partner with the Head of CSM / Chief Functional Data Officer (CfDA) Safety to shape and execute the CSM strategy, roadmap, and operating model aligned with clinical portfolio priorities.
• Advance CSM methodology within the broader Risk-Based Quality Management (RBQM) framework to support Quality by Design, data integrity, and study quality oversight, including application of Quality Tolerance Limits (QTLs) where aligned.
• Prioritize and drive enhancements to CSM systems, signal development, automation initiatives, and related RBQM analytical needs based on evolving study designs, data sources, and regulatory expectations.
• Provide statistical expertise on CSM methodologies including site-level analytics, outlier detection, trend analysis, anomaly detection, risk indicators, signal thresholds, comparative analytics, and QTL approaches.
• Lead development and validation of new or enhanced CSM signals using advanced modeling, small-sample methods, Bayesian approaches, adaptive thresholds, machine learning, and AI-enabled analytics as appropriate.
• Oversee statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring quality, traceability, and regulatory compliance.
• Support clinical study teams in understanding CSM signal outputs, statistical rationale, and appropriate follow-up actions, providing statistical judgment on unusual patterns, data quality concerns, and operational risks.
• Manage the CSM inquiry and triage model, ensuring timely routing and resolution of study team questions and signal interpretation requests.
• Lead, coach, and develop statisticians and cross-functional team members, including Amgen and Functional Service Provider resources.
• Build and maintain strong partnerships with Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality, RBQM, and Global Statistical Leads.
• Define, maintain, and enforce CSM standards, guidance, operating procedures, and best practices to ensure consistent delivery across global clinical studies.
• Support governance, documentation, and long-term sustainability of the CSM capability to ensure inspection readiness and regulatory compliance.
• Manage business-related aspects of the Software Development Life Cycle for the CSM system in collaboration with Digital Technology and statistical programming teams.
• Utilize statistical programming tools such as SAS and/or R for analytical deliverables and system validation.
• Leverage interactive visualization tools such as R Shiny and/or business intelligence platforms for signal reporting and stakeholder communication.
• Develop and implement Standard Operating Procedures (SOPs), guidance documents, and operational frameworks for CSM and related RBQM activities.
• Communicate complex statistical concepts effectively to cross-functional, globally dispersed teams in a diverse, multicultural environment.
• Stay current with regulatory and industry trends related to RBQM, clinical trial quality oversight, and centralized monitoring practices.

🎯 Requirements

• Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or related quantitative discipline with 4 years of relevant experience, OR Master’s degree with 8 years of relevant experience, OR Bachelor’s degree with 10 years of relevant experience
• Statistical experience in the biopharmaceutical industry, including clinical development
• 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 skills using SAS and/or R
• People management, functional leadership, coaching, or matrix leadership experience

🏖️ Benefits

• Comprehensive employee benefits package including retirement and savings plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible
• Career development opportunities

Skills & Technologies

Senior

Remote

Degree Required

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Amgen Inc.

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About Amgen Inc.

Amgen Inc. is a global biotechnology company headquartered in Thousand Oaks, California. Founded in 1980, it discovers, develops, manufactures, and delivers human therapeutics targeting cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Using advanced recombinant DNA and molecular biology techniques, Amgen produces biologic medicines such as Neulasta, Enbrel, and Prolia. The company operates R&D, manufacturing, and distribution facilities worldwide, investing heavily in genomic research to identify novel drug targets. Amgen also partners with academic institutions and smaller biotechs to expand its pipeline, aiming to transform breakthrough science into therapies that significantly improve patients’ lives.

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