Principal Statistical Programmer — SAS & R (Remote)

Quest Global; Barcelona; Remote; EUR 70,000 - 120,000; Full time

Job summary

Quest Global seeks a Senior/Principal Statistical Programmer to work remotely on pharmaceutical client projects. You will implement reporting and analysis across trials, generate SDTM/ADaM datasets, and lead CRO programming efforts with high quality and timely delivery.

Responsibilities include developing SAS and R programs, contributing to study reports and regulatory submissions, and ensuring adherence to regulatory guidelines and data standards.

Qualifications

• Extensive experience in statistical programming for clinical trials.
• Ability to generate SDTM/ADaM datasets and specs.
• Experience overseeing CRO programmers and regulatory deliverables.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml.
• Develop SAS programs for datasets, tables, listings, graphs and analyses.
• Deliver high-quality programming results and validate SAS/R programs.
• Oversee CRO deliverables to ensure quality and timelines.
• Support preparation of study reports, regulatory submissions and exploratory analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Create and maintain standards for programming tools and macros.
• Develop CRF edits, data validation plans and data checks.

Skills

Statistical programming

Clinical data analysis

Regulatory knowledge (FDA/ICH)

Tools

SAS

R

SDTM

ADaM

Job description

Quest Global seeks a Senior/Principal Statistical Programmer to work remotely on pharmaceutical client projects. You will implement reporting and analysis across trials, generate SDTM/ADaM datasets, and lead CRO programming efforts with high quality and timely delivery.

Responsibilities include developing SAS and R programs, contributing to study reports and regulatory submissions, and ensuring adherence to regulatory guidelines and data standards.