Centralized Statistical Monitoring, Senior Manager
Core
Provide statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM) to ensure study quality oversight is scientifically rigorous, scalable, and inspection-ready.
Role type
Senior Manager, Centralized Statistical Monitoring
Builds
CSM analysis system, signal framework, and analytical workflows supporting clinical study quality oversight
Domain
Biopharmaceutical / Clinical Development / Quality Management
Deliverable
production ML models
Required skills
Statistical programming (SAS, R), CSM methodology, Risk-Based Quality Management (RBQM), Quality Tolerance Limits (QTL), Bayesian methods, hierarchical modeling, machine learning, advanced analytics, SOP development, cross-functional leadership
Preferred skills
Biopharmaceutical industry experience, interactive visualization tools (R Shiny, BI platforms), adaptive thresholds, AI-enabled analytics, matrix leadership
Technologies
SAS, R, R Shiny
Responsibilities
Define and maintain CSM standards and operating procedures; lead business aspects of the Software Development Life Cycle for the CSM system; lead statistical review and release of CSM signals; coach and develop statisticians; partner with cross-functional stakeholders on strategy and roadmap
Seniority
Senior, hands-on IC with team leadership
