Principal Statistical Programmer (Remote) - SAS, R, CDISC

Guidewire Software; Santander; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to join our remote team working with a pharmaceutical client under Cytel's sponsorship model.

You will lead programming activities across SDTM/ADaM, DSURs and regulatory submissions, while overseeing CROs to ensure timely, high-quality deliverables. The role requires 7+ years' experience in biostatistics programming, expert SAS, and strong knowledge of CDISC standards, FDA/ICH guidelines, and collaborative leadership.

Qualifications

• Bachelor 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 CDISC standards experience (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions with FDA/ICH.
• Must be able to work independently.
• Outstanding communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables and graphs
• Provide high-quality programming outputs and validate SAS and/or R programs
• Oversee CRO programmers to meet timelines and quality
• Support preparation of clinical study reports, regulatory submissions and DSURs
• Follow FDA regulations and GCP for electronic submissions
• 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 internal/external partners to meet timelines and goals
• Draft SOPs and Work Instructions for programming practices

Skills

SAS programming

CDISC SDTM/ADaM

Clinical trial data analysis

R programming

Regulatory submissions

Independent worker

Leadership

Education

Bachelor's degree in CS/Math/Statistics

Tools

Unix/Linux

Git

Python

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to join our remote team working with a pharmaceutical client under Cytel's sponsorship model.

You will lead programming activities across SDTM/ADaM, DSURs and regulatory submissions, while overseeing CROs to ensure timely, high-quality deliverables. The role requires 7+ years' experience in biostatistics programming, expert SAS, and strong knowledge of CDISC standards, FDA/ICH guidelines, and collaborative leadership.