Principal Statistical Programmer - SAS / R (Remote)

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

Job summary

Tandem Healthcare Group is seeking a Senior/Principal Statistical Programmer (Remote) to work with a Global pharmaceutical client on statistical programming across multiple studies. This role focuses on SDTM/ADaM development, SAS and R programming, and oversight of CRO deliverables to ensure high-quality data and timely submissions.

You will operate with minimal supervision and contribute to regulatory documents and scientific publications.

Qualifications

• Extensive experience in SAS and R for clinical trial data analysis.
• Proven ability to lead programming deliverables for CROs.
• Familiarity with FDA regulations and electronic submissions.

Responsibilities

• Generate SDTM, ADaM datasets and define.xml for studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality programming results with SAS and R.
• Oversee CROs' statistical programming deliverables to meet timelines.
• Support preparation of study reports, regulatory submissions and DSURs.
• Ensure compliance with FDA regulations and GCP for submissions.
• Contribute to standards for programming tools and macros.
• Develop CRFs, edit check specs and data validation plans.
• Provide review and feedback on programming work.

Skills

SAS

R programming

Clinical statistics

SDTM/ADaM

Tools

SDTM tooling

define.xml

Job description

Tandem Healthcare Group is seeking a Senior/Principal Statistical Programmer (Remote) to work with a Global pharmaceutical client on statistical programming across multiple studies. This role focuses on SDTM/ADaM development, SAS and R programming, and oversight of CRO deliverables to ensure high-quality data and timely submissions.

You will operate with minimal supervision and contribute to regulatory documents and scientific publications.