Lead Statistical Programmer - Medical Affairs - Remote

Overview

We are seeking a highly skilled Lead Statistical Programmer to join our Medical Affairs team. This is a technical individual contributor role—ideal for a senior programmer who enjoys full study ownership, heavy hands-on coding, and solving complex real-world data challenges. You will support Phase IV, observational, and HEOR studies contributing to scientific publications, value dossiers, and post-marketing safety analyses.

In Short

• Hands-on Programming: Develop and validate SDTM, ADaM datasets, and TFLs using SAS (and optionally R).
• Write study-specific macros and reusable programs for automation and efficiency.
• Perform ad-hoc programming for publications, safety reports, and value communications.
• Study-Level Technical Leadership: Serve as the primary programming point of contact for multiple Medical Affairs studies.
• Create and manage timelines, resolve programming issues, and ensure deliverable quality.
• Collaborate with biostatisticians, medical writers, HEOR analysts, and data managers.
• Ensure programming is consistent with CDISC, company SOPs, and regulatory expectations.
• Conduct QC reviews, and support audit readiness for programming deliverables.

Requirements

• Bachelor's or Master’s in Biostatistics, Computer Science, or a related field.
• 8+ years of SAS programming experience in a clinical or medical affairs setting.
• Deep experience with SDTM/ADaM development, TLF programming, and publication outputs.
• Proven ability to lead programming independently across multiple studies.
• Strong understanding of ICH guidelines, CDISC standards, and real-world data structure.

Benefits

• Excellent work-life balance.
• Quality-focused, collaborative culture.
• Opportunities for professional development.
• Engagement in meaningful work that contributes to people's lives.