Centralized Statistical Monitoring, Senior Manager

Career CategoryClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Centralized Statistical Monitoring - Senior ManagerWhat you will doLet’s do this. Let’s change the world. 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.AccountabilitiesServe 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.Key ResponsibilitiesStrategic and Operational LeadershipSupport the continued development of CSM within the broader RBQM framework. Translate portfolio needs, study team feedback, regulatory expectations, and technical considerations into clear business, statistical, and operational requirements.Define and maintain CSM standards, guidance, operating procedures, and best practices to support consistent delivery across studies.CSM System OwnershipLead business-related aspects of the Software Development Life Cycle for the CSM system, including requirements definition, prioritization, user acceptance testing, business validation, release readiness, and lifecycle management.Partner with Digital Technology and statistical programming colleagues to support system strategy, production implementation, testing, documentation, and continuous improvement.Methodology and InnovationProvide statistical expertise on CSM methodology, including site-level analytics, outlier detection, trend analysis, anomaly detection, risk indicators, signal thresholds, comparative analytics, and QTL approaches where applicable.Lead or support the development of new and enhanced CSM signals in response to evolving study designs, endpoint types, data sources, and portfolio needs. Evaluate innovative approaches, including advanced modeling, small-sample methods, Bayesian approaches, adaptive thresholds, machine learning, and AI-enabled analytics where appropriate.Study Support and Signal DeliveryLead statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring quality and traceability.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.Support the CSM inquiry and triage model for study team questions, escalations, and signal interpretation requests, ensuring requests are routed and addressed appropriately.Team Leadership and Cross-Functional PartnershipLead, coach, and develop statisticians and colleagues supporting CSM activities, including Amgen and Functional Service Provider resources as appropriate.Build strong partnerships across Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality, RBQM, Global Statistical Leads, and other cross-functional stakeholders.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The person we seek is a professional with these qualifications.Basic Qualifications:Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 4 years of relevant experience, ORMaster’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience, ORBachelor’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 10 years of relevant experiencePreferred QualificationsStatistical 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 monitori