Centralized Statistical Monitoring, Director

Amgen

Haematology and Oncology

Rotkreuz - Schweiz

Manager / Team Leader

Hybrid

Experteer 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.

Compensation / 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

Responsibilities

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

Key requirements

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

Description

You will provide strategic, statistical, and operational leadership for Amgen’s Centralized Statistical Monitoring (CSM) within the RBQM fra…

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