Remote Principal Statistical Programmer (SAS + R)

Arra Experiencias Lingüísticas

Ejea de los Caballeros

Remote

EUR 107,000 - 143,000

Full time

6 days ago
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Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead SAS and R programming for global clinical trials. You will develop SDTM/ADaM datasets and outputs, validate complex listings, and support regulatory submissions under GxP guidelines.

The role involves supervising CRO programmers, ensuring high-quality results, and contributing to CSRs and exploratory analyses in a fully embedded sponsor setting.

Qualifications

  • Clinical trials expertise with regulatory data handling.
  • Experience delivering SDTM/ADaM outputs and specs.
  • Strong knowledge of FDA regulations and GCP guidance.

Responsibilities

  • Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
  • Develop SAS programs to produce datasets, listings, tables and graphs for analyses
  • Deliver high-quality programming results and maintain SAS/R programs for trials
  • Oversee CRO programming deliverables to meet timelines and quality
  • Support creation of clinical study reports, regulatory submissions, and DSURs

Skills

SAS programming
R programming
SDTM/ADaM
Clinical trials
GxP compliance

Education

Master's in Biostatistics
PhD in Biostatistics

Tools

SAS
R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead SAS and R programming for global clinical trials. You will develop SDTM/ADaM datasets and outputs, validate complex listings, and support regulatory submissions under GxP guidelines.

The role involves supervising CRO programmers, ensuring high-quality results, and contributing to CSRs and exploratory analyses in a fully embedded sponsor setting.

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