Principal Statistical Programmer (SAS + R) - Remote

Jobgether; Santiago de Compostela; Remote; EUR 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely and integrate with a sponsor-dedicated team. You will develop SAS and R programs for clinical trials, generate datasets, listings, and graphs, and ensure high-quality data outputs while collaborating with CROs and a biostatistics team.

You will be responsible for SDTM/ADaM specifications, define.xml, regulatory submissions, and adherence to FDA guidelines.

Qualifications

• Senior-level pharmaceutical statistical programming experience preferred.
• Experience delivering SDTM/ADaM specifications and defining.xml files.
• Ability to review CRO deliverables and ensure high quality data outputs.

Responsibilities

• Develop SAS programs to generate datasets, listings, tables and graphs for clinical trials.
• Create and maintain SDTM/ADaM specifications and define.xml for studies.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports and regulatory submissions.
• Ensure compliance with FDA regulations and good clinical practice.

Skills

SAS

R

SDTM

ADaM

define.xml

Tools

CRFs

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely and integrate with a sponsor-dedicated team. You will develop SAS and R programs for clinical trials, generate datasets, listings, and graphs, and ensure high-quality data outputs while collaborating with CROs and a biostatistics team.

You will be responsible for SDTM/ADaM specifications, define.xml, regulatory submissions, and adherence to FDA guidelines.