Principal Statistical Programmer - SAS + R (Remote)

Fábrica De Papel De Regalo Y Bolsas De Papel; Morcín; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on global pharma projects. You will lead programming activities, develop SDTM/ADaM datasets, and deliver high-quality outputs with limited supervision.

You will oversee CRO programmers, support regulatory submissions and DSURs, and ensure adherence to FDA/ICH guidelines, with a focus on reproducibility and standards development. Strong communication and leadership are required.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in biotech/pharma biometrics.
• Exceptional SAS programming and CDISC experience.
• Regulatory submissions experience with FDA/ICH guidelines.
• Ability to work independently with strong communication.

Responsibilities

• Generate SDTM, ADaM specs, datasets, define.xml for multiple studies.
• Develop SAS programs to create datasets, tables, listings, graphs.
• Deliver high-quality SAS/R outputs and oversee CRO programmers.
• Support clinical study reports, regulatory submissions, DSURs.
• Ensure compliance with FDA/ICH regulations and standards.
• Collaborate with internal/external partners to meet timelines.

Skills

CDISC standards (SDTM/ADaM/Define.xml)

Independent work

Leadership

Communication

Regulatory experience with FDA/ICH

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on global pharma projects. You will lead programming activities, develop SDTM/ADaM datasets, and deliver high-quality outputs with limited supervision.

You will oversee CRO programmers, support regulatory submissions and DSURs, and ensure adherence to FDA/ICH guidelines, with a focus on reproducibility and standards development. Strong communication and leadership are required.