Principal Statistical Programmer - SAS/R (Remote)

Elpuertodesantamaria; Marbella; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) for remote work, embedded with a pharmaceutical client. You will lead programming activities for SDTM/ADaM, develop datasets, tables, listings, and graphics, and oversee CRO deliverables with a focus on quality and timely submission.

The role requires extensive CDISC know-how, strong communication, and independence to drive regulatory submissions and study reports across therapeutic areas.

Qualifications

• Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently with strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables (including descriptive and inferential), and complex graphs.
• Deliver high-quality statistical programming results, maintaining SAS and/or R programs.
• Oversee CRO programmers to ensure high-quality deliverables and timelines.
• Support preparation of CSRs, regulatory submissions, publications, DSURs, and exploratory analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review/author data transfer specifications for external data.
• Collaborate with internal and external partners to meet project goals.
• Create and review SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC (SDTM/ADaM)

Regulatory submissions

Leadership/communication

Education

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

Tools

Python

Unix/Linux

Git

Shiny

Job description

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) for remote work, embedded with a pharmaceutical client. You will lead programming activities for SDTM/ADaM, develop datasets, tables, listings, and graphics, and oversee CRO deliverables with a focus on quality and timely submission.

The role requires extensive CDISC know-how, strong communication, and independence to drive regulatory submissions and study reports across therapeutic areas.