Senior Principal Statistical Programmer (SAS + R) - Remote

Farmacia Con Atención Al Usuario Personalizada; Granada; Remote; EUR 107.000 - 161.000; Vollzeit

Zusammenfassung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (remote) to lead programming activities for one or more global pharmaceutical clients. You will implement reporting and analysis activities, oversee CRO programmers, and ensure high-quality data delivery for sponsor trials.

Ideal candidates have a strong SAS skill set, CDISC standards experience, and a track record with regulatory submissions. This role emphasizes independent work, leadership, and collaboration across CROs and

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years as a Statistical Programmer in biotech/pharma or similar team.
• Exceptional SAS programming and experience with SDTM/ADaM and Define.xml.
• Extensive CDISC standards experience and FDA/ICH regulatory knowledge.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.

Aufgaben

• Generate SDTM/ADaM specifications, datasets, reviewers' guides and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R programming results and validate programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and DSURs.

Kenntnisse

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions experience

Independent working

Leadership/communication skills

Ausbildung

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

R

Python

Unix/Linux

Git

Shiny

Jobbeschreibung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (remote) to lead programming activities for one or more global pharmaceutical clients. You will implement reporting and analysis activities, oversee CRO programmers, and ensure high-quality data delivery for sponsor trials.

Ideal candidates have a strong SAS skill set, CDISC standards experience, and a track record with regulatory submissions. This role emphasizes independent work, leadership, and collaboration across CROs and