Principal Statistical Programmer (SAS + R) – Remote

Farmacia Con Atención Al Usuario Personalizada; Talavera de la Reina; A distancia; EUR 125.000 - 170.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-driven program. You will lead programming for SDTM/ADaM, develop complex datasets, listings and graphs, and oversee CRO deliverables across studies.

Collaboration with biostatistics and regulatory teams is essential. Ideal candidates have 7+ years in biotech/pharma programming, strong SAS skills, CDISC standards expertise, and experience with regulatory submissions.

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and CDISC SDTM/ADaM experience.
• Experience supporting regulatory submissions and interactions with authorities.
• Ability to work independently with strong communication and leadership.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Oversee CRO programmers to ensure high-quality deliverables on time.
• Support clinical study reports, regulatory submissions and DSURs.
• Follow FDA regulations and develop programming standards and macros.
• Contribute to CRF development, data validation plans and SOPs.

Conocimientos

SAS programming

R programming

Leadership

Independent worker

Communication skills

Educación

Bachelor's degree in computer science / data science / mathematics / statistics

Herramientas

SAS

R

Python

Java

Shiny

Unix/Linux

git

Markdown

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-driven program. You will lead programming for SDTM/ADaM, develop complex datasets, listings and graphs, and oversee CRO deliverables across studies.

Collaboration with biostatistics and regulatory teams is essential. Ideal candidates have 7+ years in biotech/pharma programming, strong SAS skills, CDISC standards expertise, and experience with regulatory submissions.