Principal Statistical Programmer (SAS & R) – Remote

AniCura España; Sevilla; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to join its FSP Services team. You will be dedicated to one global pharmaceutical client, delivering high-quality programming for SDTM/ADaM, CSR support and regulatory submissions.

You will develop SAS and R programs, oversee CRO deliverables, and contribute to standards while ensuring compliance with FDA guidelines and GxP practices across studies.

Qualifications

• Experience in clinical programming for SxS and regulatory submissions.
• Ability to produce SDTM/ADaM datasets, tables, listings and figures.
• Knowledge of FDA/ICH regulations for electronic submissions.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewers guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical programs' needs.
• Oversee CROs' programming deliverables to ensure quality and timelines.
• Support preparation of CSR, regulatory submissions, publications and DSUR.
• Understand FDA regulations affecting reporting of trial data (GCP).
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks and data validation plans.

Skills

SAS

R

SDTM/ADaM

CRO oversight

GxP knowledge

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to join its FSP Services team. You will be dedicated to one global pharmaceutical client, delivering high-quality programming for SDTM/ADaM, CSR support and regulatory submissions.

You will develop SAS and R programs, oversee CRO deliverables, and contribute to standards while ensuring compliance with FDA guidelines and GxP practices across studies.