Principal Statistical Programmer (SAS + R) – Remote

Marex

Madrid

À distance

EUR 85 000 - 115 000

Plein temps

Il y a 5 jours
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Avantages offerts par ce poste

Remote work

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with a sponsor-dedicated team, delivering high-quality SDTM/ADaM outputs and supporting regulatory submissions. The role involves overseeing CRO programmers, developing SAS and R programs, generating tables, listings, and figures, and ensuring compliance with FDA/ICH guidelines.

Ideal candidates have a BA/BS in a quantitative field, 7+ years of Biotech/Pharma experience, and strong leadership and communication skills in

Qualifications

  • Bachelor's degree in a quantitative field (computer science, data science, mathematics, or statistics).
  • 7+ years of experience as a Statistical Programmer in Biotech/Pharma Biometric Teams.
  • Expert SAS programming and SDTM/ADaM knowledge with Define.xml.
  • Experience with regulatory submissions and FDA/ICH guidance.
  • Ability to work independently and lead teams.

Responsabilités

  • Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
  • Develop SAS programs to create datasets, listings, tables and complex graphs.
  • Deliver high-quality SAS/R programming solutions for clinical programs.
  • Oversee CRO programmers to meet timelines and quality standards.
  • Support regulatory submissions, CSR preparation, DSURs, and exploratory analyses.

Connaissances

SAS programming
CDISC standards
Regulatory submissions experience
Leadership
Communication

Formation

Bachelor's degree in computer science, data science, mathematics, or statistics

Outils

R
Python
Java
Shiny
Unix/Linux
git

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with a sponsor-dedicated team, delivering high-quality SDTM/ADaM outputs and supporting regulatory submissions. The role involves overseeing CRO programmers, developing SAS and R programs, generating tables, listings, and figures, and ensuring compliance with FDA/ICH guidelines.

Ideal candidates have a BA/BS in a quantitative field, 7+ years of Biotech/Pharma experience, and strong leadership and communication skills in

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