Centralized Statistical Monitoring, Senior Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Centralized Statistical Monitoring, Senior Manager based in United States. This senior leadership role provides statistical, technical, operational, and business direction for centralized statistical monitoring (CSM) across a growing clinical portfolio. You will help ensure study oversight is scientifically rigorous, scalable, inspection-ready, and aligned with evolving clinical and regulatory needs. The position combines strategic leadership with hands-on expertise in statistical methodology, analytical systems, signal development, and study support. You will help advance CSM within the broader Risk-Based Quality Management framework while exploring innovative approaches to improve quality and data integrity. The role also offers significant cross-functional exposure across Statistics, Technology, Programming, Data Management, Clinical Operations, and Quality. It is an opportunity to shape a critical capability while leading teams and influencing how clinical studies are monitored and supported. Accountabilities: - Serve as the business owner for the centralized statistical monitoring analysis system, signal framework, and associated analytical workflows, ensuring effective governance, sustainability, and continuous improvement. - Lead the CSM Statistics team and maintain accountability for statistical deliverables supporting the broader monitoring capability. - Partner with senior CSM and safety leadership to develop and execute the CSM strategy, roadmap, operating model, and portfolio priorities. - Advance CSM methodology within the Risk-Based Quality Management framework, supporting Quality by Design, data quality, data integrity, and effective study oversight.

- Prioritize system enhancements, new signals, automation opportunities, and related analytical initiatives, including Quality Tolerance Limit approaches where aligned with portfolio needs. - Define and maintain CSM standards, guidance, procedures, and best practices to promote consistent delivery across clinical studies. - Lead business-related activities within the CSM software development lifecycle, including requirements definition, prioritization, user acceptance testing, business validation, release readiness, and lifecycle management. - Provide statistical expertise across site-level analytics, outlier and anomaly detection, trend analysis, risk indicators, signal thresholds, comparative analytics, and other monitoring approaches. - Lead or support the development and evaluation of new CSM signals in response to changing study designs, endpoints, data sources, and portfolio requirements, including advanced modeling, Bayesian approaches, machine learning, and AI-enabled analytics where appropriate. - Oversee statistical review, interpretation, documentation, and release of CSM signals, ensuring quality, consistency, and traceability. - Support study teams in interpreting signal outputs, understanding statistical rationale, and determining appropriate follow-up actions related to unusual patterns, data quality concerns, operational risks, or potential study- and site-level issues. - Support CSM inquiry and triage processes, ensuring questions and escalations are appropriately addressed and routed. - Lead, coach, and develop statisticians and other resources supporting CSM activities, including external or Functional Service Provider resources as appropriate. - Build strong partnerships across Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality, RBQM, Global Statistical Leads, and other cross-functional teams. - Contribute to governance, inspection readiness, documentation, market initiatives, and long-term improvement of the CSM capability.