Senior Principal Statistical Programmer - Remote SAS/R

Nortempo Empresa De Trabajo Temporal SL; La Coruña; Remote; EUR 60,000 - 90,000; Full time

Job summary

Nortempo Empresa De Trabajo Temporal SL is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role embedded with a leading pharmaceutical client. You will work within Cytel's FSP Services, delivering high-quality programming for SDTM/ADaM datasets and SAS-based analyses across multiple studies.

The ideal candidate has 7+ years of Biotech/Pharma experience, strong CDISC expertise, and a proven ability to lead CRO programming deliverables under FDA/ICH guidelines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and CDISC standards (SDTM, ADaM, Define.xml).
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently and lead CRO programming deliverables.

Responsibilities

• + Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• + Develop SAS programs to generate datasets, complex listings, tables and graphs
• + Deliver high-quality programming results using SAS and/or R
• + Oversee CROs' programming deliverables to meet timelines
• + Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses
• + Understand and follow FDA regulations for electronic submissions
• + Contribute to standards for programming tools, outputs, and macros
• + Develop CRFs, edit check specs, and data validation plans
• + Provide data transfer specifications for external vendor data
• + Collaborate with internal and external partners to meet project goals
• + Provide SOPs and Work Instructions related to statistical programming practices

Skills

SAS programming

CDISC standards

SDTM

ADaM

Define.xml

Regulatory submissions

Leadership

R

Python

Unix/Linux

Git

Shiny

Markdown

Education

Bachelor's degree in computer science/data science/mathematics/statistics

Tools

SAS

R

Python

Unix/Linux

Git

Shiny

Markdown

Job description

Nortempo Empresa De Trabajo Temporal SL is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role embedded with a leading pharmaceutical client. You will work within Cytel's FSP Services, delivering high-quality programming for SDTM/ADaM datasets and SAS-based analyses across multiple studies.

The ideal candidate has 7+ years of Biotech/Pharma experience, strong CDISC expertise, and a proven ability to lead CRO programming deliverables under FDA/ICH guidelines.