Centralized Statistical Monitoring, Director

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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, Director

Let’s do this. Let’s change the world. In this vital role you will provide strategic, statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM). The role is 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) and study quality oversight strategy.

The successful candidate will 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. The role may also support related RBQM analytical needs, including Quality Tolerance Limit (QTL) approaches, where aligned with CSM scope and portfolio priorities.

• 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.

• Lead the strategic development, operating model, roadmap, and continued evolution of Amgen’s Centralized Statistical Monitoring capability within the broader RBQM framework.
• Serve as business owner for the CSM analysis system, partnering with Digital Technology and Statistical Programming on requirements, prioritization, SDLC activities, business validation, UAT, release readiness, lifecycle management, and continuous improvement.
• Provide senior statistical and technical leadership for conventional and innovative CSM methodology, including signal development, site‑level analytics, anomaly detection, risk indicators, signal thresholds, QTL‑related approaches where applicable, and advanced statistical, machine learning, or AI‑enabled approaches where appropriate.
• Oversee statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring outputs are…