Senior Principal Statistical Programmer (SAS + R) – Remote

Between Group; Oviedo; Remote; EUR 80,000 - 116,000; Full time

Job summary

Between Group is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming activities within sponsor-driven clinical trials. You will work with SAS and R to deliver SDTM/ADaM datasets, tables, listings and figures, while supervising CRO programmers to ensure quality and timelines.

The role requires extensive experience in clinical development, regulatory submissions, and a strong understanding of FDA guidelines and eSubmissions.

Qualifications

• Senior-level statistical programming experience in clinical trials.
• Ability to lead programming activities and oversee CRO deliverables.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs that generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results using SAS and/or R tailored to clinical development programs
• Oversee CROs' statistical programming deliverables for multiple studies to ensure quality and timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR and exploratory analyses
• Understand FDA regulations affecting reporting of trial data, including GCP and electronic submissions
• Contribute to creation, maintenance, and validation of programming standards, tools, outputs, and macros
• Participate in development of CRFs, edit check specs, and data validation plans
• Provide review

Tools

SAS

R

Job description

Between Group is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming activities within sponsor-driven clinical trials. You will work with SAS and R to deliver SDTM/ADaM datasets, tables, listings and figures, while supervising CRO programmers to ensure quality and timelines.

The role requires extensive experience in clinical development, regulatory submissions, and a strong understanding of FDA guidelines and eSubmissions.