Principal Statistical Programmer

About the role

The Principal Statistical Programmer is a senior contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables that support clinical trials and regulatory submissions. This remote position works across Europe or LATAM and collaborates closely with biostatistics, data management, and clinical teams.

Key responsibilities

• Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
• Program complex tables, listings, and figures (TLFs) for study reports, publications, and submissions.
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation.
• Serve as lead programmer on multiple studies, coordinating efforts across internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Ensure all programming deliverables comply with CDISC, FDA, EMA, and internal SOPs.
• Contribute to programming standards, reusable code libraries, and quality‑control processes.
• Prepare submission‑ready datasets, define.xml files, and reviewer guides for regulatory authorities.
• Support integrated safety and efficacy summaries for NDA/BLA/MAA submissions using tools such as Pinnacle 21, OpenCDISC, and define.xml generators.

Required profile

• Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field.
• 7‑9 years of statistical programming experience in the pharmaceutical, biotech, or CRO industry.
• Expert‑level proficiency in SAS Base, SAS Macro, and SAS SQL.
• In‑depth experience with CDISC SDTM and ADaM standards.
• Proven track record supporting clinical trial reporting and regulatory submissions.
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA/EMA regulatory expectations.
• Excellent problem‑solving, communication, and collaboration skills.

Required skills

• SAS Base
• SAS Macro
• SAS SQL
• CDISC SDTM
• CDISC ADaM
• Pinnacle 21
• OpenCDISC
• define.xml generators