Senior Principal Statistical Programmer (SAS + R) Remote

LHH Recruitment Solutions; Madrid; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role supporting a pharmaceutical client. You will lead SDTM/ADaM data handling, develop complex tables and graphs, and guide CRO programmers to ensure high-quality, compliant outputs for regulatory submissions.

The role requires 7+ years in biotech/pharma programming, strong CDISC and FDA/ICH expertise, and independent work with leadership capabilities. Remote with global collaboration opportunities.

Formación

• Bachelor's degree in computer science, data science, mathematics, or statistics (preferred).
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development or related field.
• Excellent SAS programming skills and experience with statistical programming procedures in a clinical environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory guidelines (FDA/ICH).
• Ability to work independently; strong communication and leadership skills.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, complex listings/tables, and graphs.
• Deliver high-quality SAS/R outputs and maintain programming standards across studies.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of CSRs, regulatory submissions, publications, DSUR, and exploratory analyses.
• Ensure compliance with FDA regulations and GxP for electronic submissions.
• Contribute to standards, tools, and macros in programming.

Conocimientos

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulation knowledge

Leadership

Communication

R programming

Unix/Linux

Python

Educación

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

Herramientas

SAS

R

Define.xml

Python

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role supporting a pharmaceutical client. You will lead SDTM/ADaM data handling, develop complex tables and graphs, and guide CRO programmers to ensure high-quality, compliant outputs for regulatory submissions.

The role requires 7+ years in biotech/pharma programming, strong CDISC and FDA/ICH expertise, and independent work with leadership capabilities. Remote with global collaboration opportunities.