Principal Statistical Programmer - SAS/R, Remote, Pharma

RubyPlay; Santiago de Compostela; À distance; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer to be fully embedded with a pharmaceutical client. You will implement reporting and analysis activities for Sponsor trials, oversee CRO work, and ensure data deliverables meet quality and regulatory standards.

Applicants should have 7+ years of experience in statistical programming in biopharma, strong SAS and R skills, and deep CDISC knowledge. This is a remote role with global collaboration and regulatory exposure.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in biopharma/clinical biometrics.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM Define.xml experience and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interacting with regulatory authorities.
• Ability to work independently.
• Strong communication and leadership skills.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS and R programs for clinical development programs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Ensure compliance with FDA regulations and GCP in reporting of trial data.
• Develop and maintain standards for programming tools, outputs, and macros.
• Contribute to CRF development, edit checks, and data validation plans.
• Provide review or author data transfer specifications for external data.

Connaissances

SAS programming

R programming

CDISC SDTM

CDISC ADaM

FDA/ICH regulations

Data reporting

Leadership

Regulatory submissions

GCP knowledge

Communication

Formation

Bachelor's degree in Computer Science/Statistics

Outils

SAS

R

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer to be fully embedded with a pharmaceutical client. You will implement reporting and analysis activities for Sponsor trials, oversee CRO work, and ensure data deliverables meet quality and regulatory standards.

Applicants should have 7+ years of experience in statistical programming in biopharma, strong SAS and R skills, and deep CDISC knowledge. This is a remote role with global collaboration and regulatory exposure.