Manager, Statistical Programming

Job Summary

Seeking a full-time remote Manager or Senior Manager of Statistical Programming, this role will manage the development of high-quality, submission-ready programming deliverables for clinical studies and regulatory submissions in the pulmonary/respiratory portfolio.

Key responsibilities:

• Develop, validate, and maintain SAS and R programs to produce CDISC-compliant datasets and TLFs for clinical studies
• Serve as lead programmer for assigned Phase 2b/3 studies, ensuring audit-ready deliverables aligned with regulatory guidelines
• Mentor junior programmers and contribute to departmental SOPs and process improvement initiatives

Required qualifications:

• Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred
• 5-7+ years of statistical programming experience in pharma, biotech, or a CRO
• Advanced proficiency in SAS and thorough knowledge of CDISC standards and regulatory submission requirements
• Proven experience as lead programmer on at least one late-phase clinical study or regulatory submission
• Strong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations