Principal Statistical Programmer (SAS + R) – Remote

Hims & Hers; Islas Baleares; A distancia; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a pharmaceutical client under Cytel’s sponsorship. The role focuses on delivering SDTM/ADaM specifications, datasets, and define.xml while supervising CRO programming deliverables and ensuring high-quality analyses for regulatory submissions.

The candidate will implement reporting and analysis activities across diverse therapeutic areas, maintain programming standards, and collaborate with

Formación

• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC SDTM, ADaM, and Define.xml
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and communicate effectively

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables and graphs
• Deliver high-quality SAS/R programs tailored to clinical development needs
• Oversee CRO programmers to meet timelines and quality targets
• Support preparation of clinical study reports, regulatory submissions and DSURs
• Contribute to creation/validation of standards for programming tools and outputs
• Develop CRFs, edit checks, and data validation plans
• Collaborate with CROs, vendors and internal teams to ensure project milestones
• Review and/or author SOPs and work instructions for programming practices

Conocimientos

SAS programming

SDTM/ADaM

CDISC standards

Statistical programming

R programming

FDA/ICH regulation

Leadership

Educación

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Herramientas

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a pharmaceutical client under Cytel’s sponsorship. The role focuses on delivering SDTM/ADaM specifications, datasets, and define.xml while supervising CRO programming deliverables and ensuring high-quality analyses for regulatory submissions.

The candidate will implement reporting and analysis activities across diverse therapeutic areas, maintain programming standards, and collaborate with