Senior Principal Statistical Programmer (SAS + R) — Remote

Deel; Sevilla; A distancia; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join our sponsor-dedicated team embedded with one of our pharmaceutical clients.

You will lead SAS and R programming for SDTM/ADaM data, create define.xml, and support regulatory submissions across studies, with limited supervision and strong collaboration with CROs. You will contribute to high-quality outputs, develop standards, and ensure adherence to FDA/ICH guidelines while mentoring junior programmers and

Formación

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or equivalent.
• Exceptional SAS programming skills and development of statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Ability to work independently.
• Outstanding communication and leadership skills.

Responsabilidades

• Generate SDTM/ADaM specifications, datasets, review guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs in collaboration with a Statistician.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables for multiple studies to ensure quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Follow FDA regulations and guidelines for electronic submissions (GCP).
• Contribute to creating, maintaining, and validating standards for programming tools and macros.
• Develop CRFs, edit checks specifications, and data validation plans.
• Provide review/author data transfer specifications for external vendors.

Conocimientos

SAS programming

R programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions

GCP/FDA regulations

Independent work

Communication skills

Leadership

Unix/Linux

Git

Educación

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

Herramientas

SAS

R

Python

Unix/Linux

Git

Shiny

Markdown

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join our sponsor-dedicated team embedded with one of our pharmaceutical clients.

You will lead SAS and R programming for SDTM/ADaM data, create define.xml, and support regulatory submissions across studies, with limited supervision and strong collaboration with CROs. You will contribute to high-quality outputs, develop standards, and ensure adherence to FDA/ICH guidelines while mentoring junior programmers and