Senior Statistical Programmer (SAS & R) — Remote

Laboratorios Normon; Madrid; Remote; EUR 116,000 - 161,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead SAS and R programming for clinical development programs. You will work within Sponsor-driven projects and oversee CROs to ensure timely, high-quality data outputs.

Responsibilities include SDTM/ADaM specs, datasets, Define.xml, and complex tables/graphs, with strong emphasis on FDA guidelines and eSubmissions.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development.
• Excellent SAS programming skills and clinical development experience.
• Strong/CDISC SDTM, ADaM, Define.xml knowledge and FDA/ICH familiarity.
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently and lead teams.

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewer’s guide, and Define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs tailored to development programs.
• Oversee CRO programming deliverables to meet timelines across studies.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations, GCP, and eSubmission guidelines.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review/author data transfer specs for external vendor data.
• Collaborate with CROs, vendors, and partners to meet project goals.
• Prepare SOPs/Work Instructions for statistical programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA regulations

Clinical trials

Leadership

Independent worker

Education

Bachelor’s degree in CS/Data Science/Math/Stats

Tools

Python

Unix/Linux

Git

Shiny

Markdown

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead SAS and R programming for clinical development programs. You will work within Sponsor-driven projects and oversee CROs to ensure timely, high-quality data outputs.

Responsibilities include SDTM/ADaM specs, datasets, Define.xml, and complex tables/graphs, with strong emphasis on FDA guidelines and eSubmissions.