Principal Statistical Programmer (SAS + R) – Remote

Deel; Córdoba; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Cytel seeks a Senior/Principal Statistical Programmer (Remote) to lead complex SAS/R programming for global clinical trials. You will develop SDTM/ADaM datasets, define.xml, and listings, while ensuring regulatory readiness and data quality.

You will oversee CRO programmers, collaborate with biostatistics teams, and contribute to study reports and submissions under GxP guidelines. Strong independence and leadership are essential.

Formación

• Bachelor's degree required in computer science, data science, mathematics, or statistics (preferred).
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development or similar.
• Exceptional SAS programming skills for clinical development environments.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interacting with FDA/global authorities.
• Ability to work independently and communicate effectively; strong leadership.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R results for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and GxP guidelines for electronic submissions.
• Create and validate programming standards, macros, and tools.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer spec reviews for external vendors.
• Collaborate with CROs, vendors, and internal stakeholders to meet goals.
• Draft SOPs and Work Instructions for statistical programming practices.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Team leadership

Independent work

R programming

GxP knowledge

Educación

Bachelor's degree in computer science, data science, mathematics, or statistics

Herramientas

SAS

R

Python

Define.xml

Unix/Linux

Git

Descripción del empleo

Cytel seeks a Senior/Principal Statistical Programmer (Remote) to lead complex SAS/R programming for global clinical trials. You will develop SDTM/ADaM datasets, define.xml, and listings, while ensuring regulatory readiness and data quality.

You will oversee CRO programmers, collaborate with biostatistics teams, and contribute to study reports and submissions under GxP guidelines. Strong independence and leadership are essential.