Principal Statistical Programmer (SAS + R) – Remote

Frontmatec; Barcelona; A distancia; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Cytel invites applications for a Senior/Principal Statistical Programmer (SAS + R) to work fully embedded with a pharmaceutical client. You will oversee CRO programmers, ensure high-quality data summaries, and drive reporting activities across studies in a remote setting.

The role requires extensive SAS programming, CDISC standards expertise, and experience with regulatory submissions. You’ll operate with minimal supervision and collaborate with internal/external partners to meet timelines and

Formación

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Biometric teams.
• Exceptional SAS programming skills in clinical development.
• CDISC SDTM/ADaM/Define.xml knowledge and FDA/ICH regulation familiarity.
• Experience supporting regulatory submissions and FDA interactions.
• Ability to work independently and lead teams.
• Excellent written and verbal communication and leadership skills.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and Define.xml files for multiple studies.
• Develop SAS programs generating datasets, listings, tables and complex graphs.
• Deliver high-quality SAS/R programming outputs for clinical development programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Ensure compliance with FDA regulations, GCP and electronic submissions guidelines.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit check specifications and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with CROs, vendors and development partners to meet project goals.
• Review SOPs and Work Instructions related to statistical programming practices.

Conocimientos

SAS programming

CDISC standards

Regulatory submissions

Leadership

Independent work

Educación

Bachelor’s degree (CS/Data Science/Math/Stats)

Herramientas

R

Python

Java

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel invites applications for a Senior/Principal Statistical Programmer (SAS + R) to work fully embedded with a pharmaceutical client. You will oversee CRO programmers, ensure high-quality data summaries, and drive reporting activities across studies in a remote setting.

The role requires extensive SAS programming, CDISC standards expertise, and experience with regulatory submissions. You’ll operate with minimal supervision and collaborate with internal/external partners to meet timelines and