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), signal development, team leadership, SOP development, regulatory knowledge
Preferred skills
Biopharmaceutical industry experience, Bayesian methods, machine learning, advanced analytics, interactive visualization tools, cross-functional partnership
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; Provide statistical expertise on site-level analytics, outlier detection, and trend analysis; Lead statistical review and release of CSM signals; Coach and develop statisticians and support staff.
Seniority
Senior, hands-on IC with leadership responsibilities