Principal Statistical Programmer (SAS + R) – Remote

Apave Portugal (Antes Eisp Qualidade); Burgos; Remote; EUR 85,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development projects. The role focuses on SAS and R programming, delivering SDTM/ADaM specifications and complex analyses for regulatory submissions.

You will oversee CRO programmers, ensure high-quality, on-time deliverables, and support study reports across multiple studies. You will work with FDA/EMA guidelines, contribute to standards, and provide expert programming support across

Qualifications

• Experience with clinical trial programming and regulatory standards (GxP, FDA/EMA)
• Strong programming in SAS; ability to deliver reproducible, auditable work
• Proven ability to oversee CRO programming deliverables and timelines

Responsibilities

• Generate SDTM/ADaM specifications and datasets
• Develop SAS/R programs for tables, listings, figures
• Deliver high-quality outputs for clinical study reports and submissions
• Supervise CRO programmers to ensure consistency and timeliness
• Support regulatory submissions and exploratory analyses
• Adhere to good clinical practice and electronic submission guidelines
• Contribute to standards for tools, outputs, and macros
• Assist in data validation plans and CRF/edit check specifications
• Provide expert programming review and troubleshooting

Skills

SAS

R programming

Statistical programming

GCP regulations

Tools

SDTM

ADaM

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development projects. The role focuses on SAS and R programming, delivering SDTM/ADaM specifications and complex analyses for regulatory submissions.

You will oversee CRO programmers, ensure high-quality, on-time deliverables, and support study reports across multiple studies. You will work with FDA/EMA guidelines, contribute to standards, and provide expert programming support across