Centralized Statistical Monitoring, Director
Amgen
July 01, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Centralized Statistical Monitoring (CSM), Director
Responsibilities / Accountabilities:
- Serve as business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
- Lead strategy, roadmap, operating model, and evolution of CSM with cross-functional stakeholders.
- Provide leadership/accountability for the CSM Statistics team and statistical deliverables.
- Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight.
- Prioritize CSM enhancements, signal development, automation opportunities, and RBQM needs (including QTL approaches where aligned).
- Lead governance, documentation, inspection readiness, lifecycle management, and sustainability of the CSM capability.
- Be senior point of accountability for CSM escalations, study team support, and alignment.
- Lead, coach, and develop CSM statisticians and supporting resources.
Key Responsibilities:
- Lead strategic development and ongoing evolution of CSM within the RBQM framework.
- Partner with Digital Technology/Statistical Programming on SDLC activities (requirements, UAT, validation, release readiness, documentation, lifecycle management).
- Provide statistical/technical leadership for signal development (site analytics, anomaly detection, risk indicators/thresholds; advanced ML/AI approaches where appropriate).
- Oversee review/interpretation/documentation/release of CSM signals; ensure traceable, inspection-ready outputs.
- Define/maintain CSM standards, guidance, training, procedures, and best practices.
Basic Qualifications:
- Doctorate in a quantitative field + 8 years relevant experience
OR Master’s in a quantitative field + 12 years relevant experience.
Preferred Qualifications:
- Biopharmaceutical clinical development/clinical trial statistical oversight; experience with CSM/RBQM/QTLs/QbD/data integrity.
- Experience developing/validating/implementing regulated monitoring signals in production.
- Business/system ownership (SDLC, UAT, validation, release readiness, lifecycle).
- SAS and/or R; Python plus; experience with clinical trial/EDC/metadata/external data.
- Familiarity with Bayesian methods, hierarchical modeling, ML/advanced analytics, R Shiny/BI.
- People management and cross-functional leadership; strong global/regulatory trend communication.
Benefits (explicitly stated): Comprehensive employee benefits, discretionary bonus/incentive, stock-based long-term incentives, time-off, and flexible work models where possible.
Application instructions:
- Apply at careers.amgen.com; no application deadline (applications accepted until sufficient number/select candidate).
Responsibilities / Accountabilities:
- Serve as business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
- Lead strategy, roadmap, operating model, and evolution of CSM with cross-functional stakeholders.
- Provide leadership/accountability for the CSM Statistics team and statistical deliverables.
- Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight.
- Prioritize CSM enhancements, signal development, automation opportunities, and RBQM needs (including QTL approaches where aligned).
- Lead governance, documentation, inspection readiness, lifecycle management, and sustainability of the CSM capability.
- Be senior point of accountability for CSM escalations, study team support, and alignment.
- Lead, coach, and develop CSM statisticians and supporting resources.
Key Responsibilities:
- Lead strategic development and ongoing evolution of CSM within the RBQM framework.
- Partner with Digital Technology/Statistical Programming on SDLC activities (requirements, UAT, validation, release readiness, documentation, lifecycle management).
- Provide statistical/technical leadership for signal development (site analytics, anomaly detection, risk indicators/thresholds; advanced ML/AI approaches where appropriate).
- Oversee review/interpretation/documentation/release of CSM signals; ensure traceable, inspection-ready outputs.
- Define/maintain CSM standards, guidance, training, procedures, and best practices.
Basic Qualifications:
- Doctorate in a quantitative field + 8 years relevant experience
OR Master’s in a quantitative field + 12 years relevant experience.
Preferred Qualifications:
- Biopharmaceutical clinical development/clinical trial statistical oversight; experience with CSM/RBQM/QTLs/QbD/data integrity.
- Experience developing/validating/implementing regulated monitoring signals in production.
- Business/system ownership (SDLC, UAT, validation, release readiness, lifecycle).
- SAS and/or R; Python plus; experience with clinical trial/EDC/metadata/external data.
- Familiarity with Bayesian methods, hierarchical modeling, ML/advanced analytics, R Shiny/BI.
- People management and cross-functional leadership; strong global/regulatory trend communication.
Benefits (explicitly stated): Comprehensive employee benefits, discretionary bonus/incentive, stock-based long-term incentives, time-off, and flexible work models where possible.
Application instructions:
- Apply at careers.amgen.com; no application deadline (applications accepted until sufficient number/select candidate).