Senior Principal Statistical Programmer – SAS & R (Remote)

Farmacias Trébol Sl; Fuengirola; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a pharmaceutical client.

The role requires a senior programmer to work independently, supervise CRO programmers, and deliver compliant data summaries and reports for regulatory submissions. You will develop SAS and R programs for SDTM/ADaM datasets, listings, and figures, contribute to CRFs and validation plans, and ensure alignment with FDA/ICH guidelines.

Qualifications

• Minimum bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills and experience in clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interaction with FDA/global authorities.
• Ability to work independently and lead teams.
• Strong written and verbal communication skills.

Responsibilities

• Generate SDTM, ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS and R programs tailored to clinical programs.
• Oversee CRO programming deliverables and ensure timelines.
• Support preparation of clinical study reports, regulatory submissions, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and macros.
• Develop CRFs, edit checks, and data validation plans.

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions experience

Independent / leadership

Communication skills

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a pharmaceutical client.

The role requires a senior programmer to work independently, supervise CRO programmers, and deliver compliant data summaries and reports for regulatory submissions. You will develop SAS and R programs for SDTM/ADaM datasets, listings, and figures, contribute to CRFs and validation plans, and ensure alignment with FDA/ICH guidelines.