Senior Principal Statistical Programmer (SAS & R) – Remote

Esss; Islas Baleares; À distance; EUR 70 000 - 120 000; Plein temps

Résumé du poste

Cytel seeks a Senior/Principal Statistical Programmer (Remote) to lead programming for clinical development programs. You will work on SDTM/ADaM specifications, datasets, and complex analyses, collaborating with statisticians and CRO partners to ensure high-quality outputs.

The role emphasizes SAS and R programming, adherence to FDA/ICH guidelines, and the development of standards for programming tools and documents across multiple studies.

Qualifications

• Extensive experience in clinical trial programming.
• Proficiency in SAS and R programming.
• Familiarity with regulatory guidelines (FDA/ICH).

Responsabilités

• Generate SDTM and ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high‑quality SAS and/or R programming outputs for clinical development.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of CSRs, regulatory submissions, publications and DSURs.
• Adhere to FDA regulations and good clinical practice for data submissions.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review data transfer specifications for external vendors.
• Collaborate with internal and external partners to meet project goals.

Connaissances

SAS

R

SDTM

ADaM

Clinical trials

Description du poste

Cytel seeks a Senior/Principal Statistical Programmer (Remote) to lead programming for clinical development programs. You will work on SDTM/ADaM specifications, datasets, and complex analyses, collaborating with statisticians and CRO partners to ensure high-quality outputs.

The role emphasizes SAS and R programming, adherence to FDA/ICH guidelines, and the development of standards for programming tools and documents across multiple studies.