Senior Statistical Programmer (SAS + R) — Remote

Altia

Oviedo

Remote

EUR 45,000 - 75,000

Full time

5 days ago
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Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely within a sponsor-dedicated program, supporting one global pharmaceutical client. The role emphasizes independence, ownership, and delivering high-quality programming across SDTM/ADaM and regulatory deliverables.

Reporting to the Director, Biostatistics and Programming, you will supervise CROs, develop SAS/R code, and contribute to study reports and submissions while adhering to FDA guidelines.

Qualifications

  • Extensive experience in clinical programming across multiple therapeutic areas.
  • Strong SAS and R programming skills with data analysis, reporting, and graphics.
  • Solid knowledge of SDTM/ADaM standards and regulatory submissions.
  • Experience overseeing CRO programmers and delivering high-quality outputs.

Responsibilities

  • Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml for studies.
  • Develop SAS programs to create datasets, listings, tables, and complex graphs.
  • Deliver high-quality SAS and R outputs tailored to clinical development needs.
  • Oversee CRO programming deliverables to meet timelines.
  • Support preparation of clinical study reports, regulatory submissions and exploratory analyses.
  • Adhere to FDA regulations and GxP for electronic submissions.
  • Contribute to standards for programming tools, outputs, and macros.
  • Develop CRFs, edit checks, and data validation plans.
  • Provide review.

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely within a sponsor-dedicated program, supporting one global pharmaceutical client. The role emphasizes independence, ownership, and delivering high-quality programming across SDTM/ADaM and regulatory deliverables.

Reporting to the Director, Biostatistics and Programming, you will supervise CROs, develop SAS/R code, and contribute to study reports and submissions while adhering to FDA guidelines.

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