Director of Centralized Statistical Monitoring

Job Summary

Leading the strategic development and operational oversight, the full-time remote Director of Centralized Statistical Monitoring will provide business leadership for the CSM analysis system, ensuring scientific rigor and alignment with regulatory and portfolio needs while managing a team of statisticians.

Key Responsibilities

• Lead the strategic development, operating model, and roadmap for Amgen's Centralized Statistical Monitoring capability within the RBQM framework
• Serve as the business owner for the CSM analysis system, collaborating with cross-functional teams on requirements and continuous improvement
• Provide senior statistical leadership for CSM methodology, ensuring outputs are scientifically sound and useful for clinical study quality oversight

Required Qualifications

• Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline with 8 years of relevant experience, or a Master's degree with 12 years of relevant experience
• Significant statistical experience in the biopharmaceutical industry, particularly in clinical development and trial oversight
• Experience with Centralized Statistical Monitoring, RBQM, and clinical trial quality oversight
• Proficiency in statistical programming using SAS and/or R, with Python experience being a plus
• People management or functional leadership experience, including leading cross-functional initiatives