Centralized Statistical Monitoring, Senior Manager

Role: Senior Manager leading Amgen's Centralized Statistical Monitoring (CSM) analysis system, providing statistical, operational, and strategic oversight to ensure study quality and regulatory compliance in clinical trials. Responsibilities include ownership of CSM analysis workflows, system enhancements, signal development, and integration within RBQM frameworks. Partnering with cross-functional teams, including Digital Technology, Data Management, and Clinical Operations, the role involves defining standards, supporting system lifecycle management, innovating with advanced statistical methodologies (e.g., Bayesian models, machine learning), and leading study signal interpretation and investigation. The position emphasizes leadership of the CSM Statistics team, development of best practices, and inspection readiness. Qualifications require a doctorate (with 4+ years experience) or master’s (8+ years), or bachelor’s (10+ years) in Statistics, Biostatistics, or related fields, with preferred experience in biopharma clinical development, regulatory analytical deliverables, and systems ownership. Skills in SAS/R, advanced analytics, visualization tools, and knowledge of QTLs, Quality by Design, and RBQM are advantageous. The role supports oncology, inflammation, or rare disease therapeutic areas, with focus on clinical trial quality oversight, and involves collaborating across global teams. The position is primarily remote with potential for cross-border coordination, and no specific travel is indicated.