Principal Statistical Programmer (SAS + R) - Remote

Groupe SEGULA Technologies SA; Ciudad Real; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one pharmaceutical client. You will implement reporting and analysis activities for sponsor trials, oversee CRO programmers, and contribute to high-quality data delivery across studies.

You will generate SDTM/ADaM specs, datasets, define.xml, and reviewers' guides; develop SAS and R programs; support regulatory submissions; ensure compliance with FDA and GCP; and help develop standards for tools and macros.

Qualifications

• Extensive experience in statistical programming for clinical trials.
• Proficient in SDTM/ADaM specifications and datasets.
• Experience overseeing CRO programmers and timelines.
• Familiar with FDA regulations and regulatory submissions.

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewers' guides and define.xml for studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality SAS and R outputs for development programs.
• Oversee CRO programming deliverables and timelines for multiple studies.
• Support preparation of clinical study reports, regulatory submissions and DSUR.
• Adhere to FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review and quality assurance.

Skills

SAS programming

R programming

Clinical data analysis

Statistical programming leadership

CRO oversight

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one pharmaceutical client. You will implement reporting and analysis activities for sponsor trials, oversee CRO programmers, and contribute to high-quality data delivery across studies.

You will generate SDTM/ADaM specs, datasets, define.xml, and reviewers' guides; develop SAS and R programs; support regulatory submissions; ensure compliance with FDA and GCP; and help develop standards for tools and macros.