Senior Principal Statistical Programmer – SAS + R (Remote)

Farmacia Con Atención Al Usuario Personalizada; Ciudad Real; A distancia; EUR 107.000 - 143.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a pharmaceutical client. The role involves delivering SDTM/ADaM specifications, datasets, and define.xml files, and leading data outputs across studies.

You will manage CROs, ensure high-quality analyses, and support regulatory submissions and DSURs. The ideal candidate has 7+ years of experience, strong SAS skills, CDISC expertise, and a proven ability to work independently with excellent

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics (preferred).
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills and experience with SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and lead with strong communication and leadership skills.

Responsabilidades

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Maintain SAS and/or R programs for clinical development programs' needs.
• Oversee CRO programmers to ensure on-time delivery of data outputs.
• Support clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses.
• Follow FDA regulations and ICH/GCP guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks specifications, and data validation plans.
• Provide data transfer specifications for external vendor data.

Conocimientos

SAS programming

CDISC standards (SDTM/ADaM/Define.xml)

Regulatory submissions experience

Independent work

Communication & leadership

Educación

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

Herramientas

R

Python

Unix/Linux

Git

Shiny / Markdown

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a pharmaceutical client. The role involves delivering SDTM/ADaM specifications, datasets, and define.xml files, and leading data outputs across studies.

You will manage CROs, ensure high-quality analyses, and support regulatory submissions and DSURs. The ideal candidate has 7+ years of experience, strong SAS skills, CDISC expertise, and a proven ability to work independently with excellent