Principal Statistical Programmer (SAS/R) - Remote

Ethos; Islas Baleares; Remote; EUR 65,000 - 90,000; Full time

Job summary

Cytel seeks a Senior/Principal Statistical Programmer (Remote) to take ownership of complex programming tasks in support of global clinical trials. You will work within sponsor environments, delivering SDTM/ADaM specifications, datasets, listings, and complex graphs using SAS and R.

You will lead CRO programmers, ensure high-quality outputs, and contribute to regulatory submissions while maintaining compliance with FDA and GCP guidelines.

Qualifications

• Experience with SAS and R in clinical trials and data analysis.
• Strong knowledge of biostatistics principles and regulatory expectations.
• Proven ability to lead and coordinate cross-functional teams in a CRO/pharma setting.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality programming outputs and maintain SAS and R code for clinical development programs
• Oversee CRO programmers and ensure timely delivery of high-quality outputs
• Support preparation of clinical study reports and regulatory submissions
• Adhere to FDA and GCP guidelines for electronic submissions
• Contribute to standards creation for programming tools, outputs, and macros
• Assist in CRFs, edit check specs, and data validation plans
• Review data transfer specifications for external vendor data
• Collaborate with CROs, vendors, and partners to meet timelines

Skills

Clinical trials

Biostatistics

Leadership

Team oversight

Tools

SAS

R

Job description

Cytel seeks a Senior/Principal Statistical Programmer (Remote) to take ownership of complex programming tasks in support of global clinical trials. You will work within sponsor environments, delivering SDTM/ADaM specifications, datasets, listings, and complex graphs using SAS and R.

You will lead CRO programmers, ensure high-quality outputs, and contribute to regulatory submissions while maintaining compliance with FDA and GCP guidelines.