Principal Statistical Programmer (SAS + R) — Remote

Farmacia Con Atención Al Usuario Personalizada; Gijón; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor projects for a global pharma client, driving high-quality data analysis and reporting with SAS and R.

You will lead programming efforts, mentor CRO programmers, and ensure timely, regulatory-compliant submissions. You will implement SDTM/ADaM specifications, generate complex tables and graphs, and contribute to CRFs and data validation plans while maintaining GCP and FDA guidelines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years experience as a Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming skills in a clinical development environment.
• Experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CROs' statistical programming deliverables and ensure timelines.
• Support preparation of CSRs, regulatory submissions, publications, and DSURs.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs and vendors to meet project goals.
• Write SOPs and work instructions for programming practices.

Skills

SAS programming

Leadership

Communication

Independence

Education

BSc/Stats/CS

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor projects for a global pharma client, driving high-quality data analysis and reporting with SAS and R.

You will lead programming efforts, mentor CRO programmers, and ensure timely, regulatory-compliant submissions. You will implement SDTM/ADaM specifications, generate complex tables and graphs, and contribute to CRFs and data validation plans while maintaining GCP and FDA guidelines.