Principal Statistical Programmer: SAS + R (Remote)

Vías Y Construcciones S.A.; Islas Baleares; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely for a high-profile pharmaceutical client. You will lead statistical programming activities and coordinate with CROs to ensure high-quality data delivery across SDTM/ADaM outputs and regulatory submissions.

The role emphasizes independent, expert-level support, adherence to GxP and FDA guidelines, and delivering robust analysis plans and reports for multiple studies.

Qualifications

• Extensive experience in SAS and R within clinical trials.
• Experience coordinating CROs and generating SDTM/ADaM outputs.
• Knowledge of FDA/ICH guidelines for electronic submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results using SAS and/or R.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of CSRs, regulatory submissions, publications, DSUR, and analyses.
• Understand FDA regulations affecting reporting of trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review and quality checks.

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely for a high-profile pharmaceutical client. You will lead statistical programming activities and coordinate with CROs to ensure high-quality data delivery across SDTM/ADaM outputs and regulatory submissions.

The role emphasizes independent, expert-level support, adherence to GxP and FDA guidelines, and delivering robust analysis plans and reports for multiple studies.