Remote Principal Statistical Programmer — SAS + R

Smart Software Group; Islas Baleares; Remote; EUR 70,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely as a sponsor-dedicated member of a pharmaceutical client team. You will be embedded with limited supervision and will oversee CRO programmers to ensure high-quality data analyses and reporting across studies.

The role involves generating SDTM/ADaM specifications, developing SAS programs for complex tables and graphs, and supporting regulatory submissions in compliance with FDA guidelines.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs, including complex statistics.
• Deliver high-quality statistical programming results with SAS and/or R tailored to clinical development needs.
• Oversee CRO statistical programming deliverables across studies, ensuring timelines and quality.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Understand and apply FDA regulations and GCP guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros; develop CRFs and data validation plans.
• Provide review of deliverables to ensure accuracy and consistency.

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely as a sponsor-dedicated member of a pharmaceutical client team. You will be embedded with limited supervision and will oversee CRO programmers to ensure high-quality data analyses and reporting across studies.

The role involves generating SDTM/ADaM specifications, developing SAS programs for complex tables and graphs, and supporting regulatory submissions in compliance with FDA guidelines.