Associate Director of Statistical Programming - job 1 of 2

Job Summary

A company is looking for an Associate Director, Statistical Programming.

Key Responsibilities

• Lead the development, validation, and documentation of statistical programming deliverables for clinical studies and regulatory submissions
• Collaborate with internal teams and CRO partners to ensure quality, consistency, and compliance with CDISC standards
• Serve as the primary programming lead across multiple studies or clinical programs

Required Qualifications

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, or related field
• Strong proficiency in SAS programming; experience with R or Python is a plus
• In-depth knowledge of CDISC standards (SDTM and ADaM) and FDA/EMA regulatory requirements
• Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings preferred
• Ability to work effectively in a lean, cross-functional, start-up environment