Centralized Statistical Monitoring, Senior Manager

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.

Requirements:

Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline with at least 4 years of relevant experience; or a master's degree in one of these fields with at least 8 years of relevant experience; or a bachelor's degree with at least 10 years of relevant experience.

Professional experience in the biopharmaceutical industry, particularly within clinical development, is preferred.

Experience with centralized statistical monitoring, Risk-Based Quality Management, Quality Tolerance Limits, Quality by Design, or clinical trial quality oversight is strongly preferred.

Demonstrated experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment.

Experience serving as a business or functional owner for an analytical system, including business-facing responsibilities across the software development lifecycle.

Strong statistical programming and analytical capabilities using SAS and/or R.

Familiarity with Bayesian methods, hierarchical modeling, machine learning, or other advanced statistical and analytical techniques.

Experience with interactive visualization tools such as R Shiny and/or business intelligence platforms.

People management, functional leadership, coaching, or matrix leadership experience, including the ability to lead complex cross-functional initiatives.

Experience developing SOPs, standards, guidance, operating procedures, or similar controlled documentation.

Strong communication, collaboration, and stakeholder-management skills, with the ability to operate effectively across globally distributed and culturally diverse teams.

Understanding of regulatory expectations and industry trends related to Risk-Based Quality Management, clinical trial quality, and centralized monitoring.

Strong strategic thinking, sound statistical judgment, and the ability to translate complex technical considerations into practical business and operational requirements.

Benefits:

Annual U.S. salary range of $154,104.15–$208,493.85 USD , with actual compensation varying based on relevant skills, experience, qualifications, and other factors.

Comprehensive health and welfare benefits for eligible employees and dependents.

Retirement and Savings Plan with company contributions.

Medical, dental, and vision coverage.

Life and disability insurance.

Flexible spending accounts.

Eligibility for a discretionary annual bonus program.

Stock-based long-term incentives.

Award-winning time-off programs.

Flexible work models where applicable to the role.

Opportunities for professional growth, career development, and advancement.

Remote work arrangement within the United States.

Sponsorship is not guaranteed for this position.

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