Overview
You will provide strategic, statistical, and operational leadership for Amgen’s Centralized Statistical Monitoring (CSM) within the RBQM framework. You’ll own the CSM system, signals, and analytics, guiding cross-functional delivery and lifecycle management. You’ll evolve methodologies to ensure quality, data integrity, and inspection readiness across a growing clinical portfolio. Expect to drive innovative approaches while aligning with regulatory and business needs. This role offers the opportunity to shape the impact of centralized monitoring on patient safety and study quality at a global scale.
Leistungen / Benefits
- comprehensive benefits package
- Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus and stock-based incentives
Verantwortungsbereiche
- Steer the development and evolution of Amgen’s CSM capability within RBQM
- Own the CSM analysis system, signals, and requirements with cross-functional partners
- Provide senior statistical leadership for traditional and innovative CSM methodologies
- Oversee signal interpretation, documentation, and release for study quality oversight
- Collaborate with study teams and stakeholders to interpret findings and escalate issues
- Coach and develop CSM statisticians and resources; manage cross-functional talent
- Define standards, training materials, procedures, and best practices for sustained delivery
Zentrale Anforderungen
- Doctorate or Master’s degree in a quantitative field with extensive relevant experience (8+ or 12+ years respectively)
- Significant biopharmaceutical industry experience in clinical development and trial oversight
- Experience with Centralized Statistical Monitoring, RBQM, QTLs, and Quality by Design
- Proven track record as business/product/capability owner for an analytical or clinical system
- Strong programming and analytical skills in SAS and/or R; Python a plus
- Familiarity with Bayesian methods, ML, R Shiny, and BI platforms
- Effective communication and global collaboration skills; regulatory and industry awareness
- People leadership, coaching, and cross-functional initiative leadership
- strong communication
- global collaboration
- leadership and coaching
- SAS
- R
- Python
Centralized Statistical Monitoring, Director in Rotkreuz Arbeitgeber: Amgen
Amgen ist ein hervorragender Arbeitgeber, der eine innovative und kollaborative Unternehmenskultur fördert, die auf der Mission basiert, Patienten mit schweren Krankheiten zu helfen. Mit einem umfassenden Leistungspaket, flexiblen Arbeitsmodellen und zahlreichen Möglichkeiten zur beruflichen Weiterentwicklung bietet Amgen seinen Mitarbeitern die Chance, nicht nur ihre Karriere zu transformieren, sondern auch einen bedeutenden Einfluss auf das Leben von Patienten weltweit auszuüben.
