Senior Principal Statistical Programmer - SAS & R (Remote)

The Door Talent; Oña; Remote; EUR 70,000 - 95,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely for a global pharmaceutical client, delivering SAS and R programs for SDTM, ADaM, and Define.xml, and supporting data transfers and report generation.

The role requires leading CRO programmers, ensuring high-quality outputs, and contributing to regulatory submissions and study reports, DSURs, and exploratory analyses, while following FDA guidelines.

Qualifications

• Bachelor's degree in CS/Data Science/Math/Statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming skills and CDISC standards experience.
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently with minimal supervision.
• Outstanding written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides, and define.xml.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs tailored to trial needs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of CSRs, regulatory submissions, publications, and DSURs.
• Collaborate with CROs and vendors to ensure timelines and quality.

Skills

SAS programming

R programming

CDISC SDTM/ADaM Define.xml

Regulatory submissions experience

Independent / leadership

Communication skills

Education

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

Tools

SAS

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely for a global pharmaceutical client, delivering SAS and R programs for SDTM, ADaM, and Define.xml, and supporting data transfers and report generation.

The role requires leading CRO programmers, ensuring high-quality outputs, and contributing to regulatory submissions and study reports, DSURs, and exploratory analyses, while following FDA guidelines.