Principal Statistical Programmer (SAS/R) – Remote

Pmfarma; Sevilla; A distancia; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with one of our global pharmaceutical clients, with Cytel providing support behind you.

You will be dedicated to the sponsor and drive data analysis and reporting with autonomy and ownership. As Principal Statistical Programmer you will develop SDTM and ADaM specifications, datasets, reviewer's guides, and define.xml files; write SAS and R programs for listings, tables, figures, and regulatory submissions;

Formación

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer on Biotech/Pharma Biostatistics teams.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM/Define.xml knowledge and FDA/ICH regulation experience.
• Experience supporting regulatory submissions and interacting with FDA/global authorities.
• Ability to work independently and lead sponsor projects.
• Strong written and verbal communication and leadership skills.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs generating datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs tailored to clinical development needs.
• Oversee CRO programmers to meet pre-specified timelines across studies.
• Support preparation of clinical study reports, regulatory submissions, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals.
• Review SOPs and Work Instructions for programming practices.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication skills

Collaboration with CROs

Educación

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

Herramientas

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with one of our global pharmaceutical clients, with Cytel providing support behind you.

You will be dedicated to the sponsor and drive data analysis and reporting with autonomy and ownership. As Principal Statistical Programmer you will develop SDTM and ADaM specifications, datasets, reviewer's guides, and define.xml files; write SAS and R programs for listings, tables, figures, and regulatory submissions;