Centralized Statistical Monitoring, Senior Manager
Core
Senior leadership role providing statistical, technical, and operational direction for Centralized Statistical Monitoring (CSM) across a clinical portfolio to ensure rigorous study oversight and data integrity.
Role type
Senior Manager, Centralized Statistical Monitoring
Builds
CSM analysis systems, signal frameworks, and analytical workflows for clinical studies
Domain
Biopharmaceutical / Clinical Development / Risk-Based Quality Management
Deliverable
production ML models
Required skills
Statistical programming (SAS, R), Bayesian methods, hierarchical modeling, machine learning, AI-enabled analytics, interactive visualization (R Shiny), SOP development, cross-functional leadership, regulatory compliance
Preferred skills
Biopharmaceutical industry experience, CSM/RBQM/QbD expertise, business owner for analytical systems
Technologies
SAS, R, R Shiny
Responsibilities
Lead CSM Statistics team and strategy; define CSM standards and procedures; develop and evaluate new CSM signals using advanced modeling; oversee statistical review and release of signals; lead business activities in the software development lifecycle; coach and develop statisticians; partner with cross-functional teams on quality and data integrity.
Seniority
Senior Manager, strategic leadership with hands-on expertise
