Principal Statistical Programmer (SAS + R) - Remote

Indra Group; Madrid; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical client projects. The role focuses on SAS and R programming, SDTM/ADaM compliance, and regulatory submissions, with CRO oversight to ensure quality and timelines.

You will operate with minimal supervision, contribute to CRFs, data validation, and data transfer specs, and ensure adherence to FDA/ICH guidelines while collaborating across internal and external teams.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills in clinical development environments
• Extensive CDISC (SDTM/ADaM/Define.xml) knowledge and FDA/ICH regulatory familiarity
• Experience supporting regulatory submissions and interaction with regulatory authorities
• Ability to work independently and lead CRO programming deliverables

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and graphs
• Deliver high-quality SAS/R programs tailored to clinical development needs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Follow FDA regulations and electronic submission guidelines

Skills

SAS programming

R programming

CDISC standards (SDTM/ADaM/Define.xml)

Regulatory submissions

Independent work

Leadership

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Java

Shiny

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical client projects. The role focuses on SAS and R programming, SDTM/ADaM compliance, and regulatory submissions, with CRO oversight to ensure quality and timelines.

You will operate with minimal supervision, contribute to CRFs, data validation, and data transfer specs, and ensure adherence to FDA/ICH guidelines while collaborating across internal and external teams.