Principal Statistical Programmer (SAS + R) — Remote

Aimen Centro Tecnológico; Berga; Remote; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Cytel in Spain invites an experienced Principal Statistical Programmer to deliver programming for global clinical trials remotely. You will work within sponsor projects embedded with a client, providing expert SAS and R programming and leading CROs.

The role focuses on creating SDTM/ADaM specifications, datasets, listings, and support for regulatory submissions, DSURs, and publications. Strong knowledge of FDA regulations and GxP is essential, with 7+ years of experience.

Qualifikationen

• 7+ years as Statistical Programmer in biotech/pharma biometrics
• Experience delivering SDTM/ADaM datasets, tables, listings and figures
• Experience supervising CROs and working with regulatory submissions

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for studies
• Develop SAS programs to generate datasets, listings, tables and graphs
• Deliver high-quality programming results including developing, validating, and maintaining SAS and/or R programs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of regulatory submissions and study reports
• Ensure compliance with FDA regulations and GxP guidance
• Contribute to standards for programming tools and macros

Kenntnisse

SAS programming

R programming

Statistical programming

SDTM/ADaM

FDA regulations

Ausbildung

Bachelor's degree in Computer Science/Data Science/Mathematics/Statistics

Tools

SAS

R

Jobbeschreibung

Cytel in Spain invites an experienced Principal Statistical Programmer to deliver programming for global clinical trials remotely. You will work within sponsor projects embedded with a client, providing expert SAS and R programming and leading CROs.

The role focuses on creating SDTM/ADaM specifications, datasets, listings, and support for regulatory submissions, DSURs, and publications. Strong knowledge of FDA regulations and GxP is essential, with 7+ years of experience.