Senior Statistical Programmer (SAS + R) — Pharma

Cytel; Abla; A distancia; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Principal Statistical Programmer to work within sponsor projects, leading programming for SDTM/ADaM, datasets and reports. You will develop SAS and R programs, guide CRO work, and support regulatory submissions in a high-quality, timely manner.

The role requires extensive clinical development experience, strong communication, and leadership, with opportunities to contribute to CRFs, data validation plans, and SOPs in a collaborative environment.

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years of statistical programming experience in Biotech/Pharma.
• Exceptional SAS programming skills in a clinical development setting.
• CDISC SDTM/ADaM and Define.xml expertise, FDA/ICH knowledge.
• Experience supporting regulatory submissions and CRO oversight.
• Strong written and verbal communication with leadership ability.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xmls.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Create and validate programming standards, CRFs and data checks.
• Collaborate with CROs, vendors and partners to meet goals.
• Draft SOPs and work instructions for statistical programming.

Conocimientos

SAS programming

CDISC standards

Regulatory submissions

independent work

leadership

communication

Educación

Bachelor's degree in CS/Data Science/Math/Stats

Herramientas

R

Python

Java

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel is seeking a Principal Statistical Programmer to work within sponsor projects, leading programming for SDTM/ADaM, datasets and reports. You will develop SAS and R programs, guide CRO work, and support regulatory submissions in a high-quality, timely manner.

The role requires extensive clinical development experience, strong communication, and leadership, with opportunities to contribute to CRFs, data validation plans, and SOPs in a collaborative environment.