Manager, Statistical Programming

Job Summary

Leading statistical programming activities in a remote/hybrid environment, the full-time Manager, Statistical Programming will provide programming expertise to support clinical studies, regulatory submissions, and ad hoc analyses while ensuring high-quality deliverables and adherence to project standards.

Key responsibilities

• Lead statistical programming for multiple studies/projects, ensuring timely and high-quality deliverables
• Develop and maintain programming documentation, including CDISC standard SDTM and ADaM specifications
• Support global regulatory submissions and mentor junior programmers in programming standards and best practices

Required qualifications

• Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline
• 8+ years of programming experience in clinical trial data processing within the biotechnology, pharmaceutical, CRO, or healthcare industry
• Proficiency in SAS programming, with knowledge of R or Python as a plus
• Strong understanding of CDISC standards and regulatory submission processes
• Hands-on programming and people management experience