Senior Statistical Programmer (SAS + R) - Remote

Randstad Argentina; Valladolid; Remote; EUR 60,000 - 90,000; Full time

Job summary

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely. You will develop SDTM/ADaM specifications, create datasets, listings, and complex tables/graphs for multicenter studies, and supervise CRO programmers to ensure high-quality results.

The role requires extensive experience in clinical development programs and a solid understanding of FDA regulations for electronic submissions, with the ability to work autonomously within a sponsor-dedicated setup.

Qualifications

• Experience in clinical development programs.
• Ability to lead CROs and coordinate across teams.
• Familiarity with FDA/GxP regulatory guidelines.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality programming outputs and validate SAS/R code tailored to study needs.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of CSRs, regulatory submissions and exploratory analyses.
• Ensure compliance with FDA regulations for electronic submissions and standards.
• Contribute to documentation and validation of programming standards.
• Assist in CRFs and data validation plans.

Skills

Statistical programming

Clinical data analysis

Tools

SAS

R

SDTM

ADaM

Job description

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely. You will develop SDTM/ADaM specifications, create datasets, listings, and complex tables/graphs for multicenter studies, and supervise CRO programmers to ensure high-quality results.

The role requires extensive experience in clinical development programs and a solid understanding of FDA regulations for electronic submissions, with the ability to work autonomously within a sponsor-dedicated setup.