Senior Principal Statistical Programmer (SAS/R) – Remote

Oxigent

Islas Baleares

Remote

EUR 90,000 - 120,000

Full time

3 days ago
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Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to join our remote team supporting a pharmaceutical client. You will lead SDTM/ADaM specification development, create datasets, listings, tables, and graphs using SAS and R, and collaborate with a statistician on analyses.

You will oversee CRO programmers, ensure high-quality outputs, contribute to regulatory submissions, and work within FDA guidelines to maintain compliant programming standards across studies.

Qualifications

  • Experience leading SDTM/ADaM specifications across multiple studies.
  • Strong SAS programming for datasets, listings, tables and graphs.
  • Experience overseeing CRO programming deliverables and timelines.
  • Regulatory submission support and data preparation for clinical study reports.

Responsibilities

  • Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
  • Develop SAS programs which generate datasets, complex listings, tables and graphs
  • Deliver high-quality statistical programming results with SAS and R
  • Oversee CRO programmers to meet timelines and maintain quality
  • Support preparation of regulatory submissions and study reports
  • Follow FDA regulations and GCP for electronic submissions
  • Contribute to standards for programming tools and macros
  • Develop CRFs and data validation plans

Skills

SAS
R
SDTM
ADaM
CRO coordination
Regulatory knowledge
Clinical trials
Data analysis

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to join our remote team supporting a pharmaceutical client. You will lead SDTM/ADaM specification development, create datasets, listings, tables, and graphs using SAS and R, and collaborate with a statistician on analyses.

You will oversee CRO programmers, ensure high-quality outputs, contribute to regulatory submissions, and work within FDA guidelines to maintain compliant programming standards across studies.

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