Centralized Statistical Monitoring, Senior Manager

📋 Description

• Serve as the business owner for the centralized statistical monitoring analysis system, signal
• Lead the CSM Statistics team and maintain accountability for statistical deliverables supporting
• Partner with senior CSM and safety leadership to develop and execute the CSM strategy, roadmap
• Advance CSM methodology within the Risk-Based Quality Management framework, supporting Quality by
• Prioritize system enhancements, new signals, automation opportunities, and related analytical
• Define and maintain CSM standards, guidance, procedures, and best practices to promote consistent

🎯 Requirements

• Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative
• Professional experience in the biopharmaceutical industry, particularly within clinical
• Experience with centralized statistical monitoring, Risk-Based Quality Management, Quality
• Demonstrated experience developing, evaluating, validating, or implementing statistical monitoring
• Experience serving as a business or functional owner for an analytical system, including
• Strong statistical programming and analytical capabilities using SAS and/or R.

🎁 Benefits

• Annual U.S. salary range of $154,104.15–$208,493.85 USD, with actual compensation varying based on
• 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.