Manager of Statistical Programming

Job Summary

A company is looking for a Manager 1, Statistical Programming.

Key Responsibilities

• Lead statistical programming activities for multiple studies/projects to ensure timely and high-quality deliverables
• Develop and maintain programming documentation, including CDISC standard SDTM and ADaM specifications
• Support global regulatory authority submissions and mentor junior programmers

Required Qualifications

• Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline
• 8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO, or healthcare industry
• Proficiency in SAS programming; knowledge of R or Python is a plus
• Strong understanding of pharmaceutical clinical development and regulatory submissions
• Experience in implementing CDISC standards and regulatory guidance