Senior Manager, Statistical Programming

Job Summary

Leading statistical programming activities in a remote/hybrid capacity, the full-time Senior 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 CDISC standards.

Key responsibilities:

• Oversee statistical programming activities for multiple studies, ensuring 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 in programming standards and practices

Required qualifications:

• Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline
• 10+ years of programming experience in processing clinical trial data within the biotechnology, pharmaceutical, CRO, or healthcare industry
• Proficiency in SAS programming with a strong understanding of statistical concepts and regulatory submissions
• Excellent knowledge of CDISC standards and regulatory guidance
• Experience in mentoring and managing programming teams, with strong organizational and interpersonal skills