Senior Principal Statistical Programmer (SAS + R) – Remote

Mancomunidad De Tierras De Medina; Valladolid; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within one of our pharmaceutical clients, backed by Cytel. You will be at the heart of data analysis, with autonomy and ownership over programming tasks.

You will lead the creation of SDTM/ADaM datasets, develop SAS and R programs, and oversee CROs to deliver high-quality results for regulatory submissions and studies.

Qualifications

• Extensive experience in clinical programming for multiple studies.
• Proficient in SAS and R for data analysis and reporting.
• Knowledge of SDTM/ADaM standards and FDA guidelines.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables, and graphs
• Deliver high-quality statistical programming results and validate SAS and/or R programs
• Oversee CRO's programming deliverables to meet timelines
• Support clinical study reports, regulatory submissions, publications
• Ensure compliance with FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide review

Skills

SAS programming

R programming

SDTM

ADaM

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within one of our pharmaceutical clients, backed by Cytel. You will be at the heart of data analysis, with autonomy and ownership over programming tasks.

You will lead the creation of SDTM/ADaM datasets, develop SAS and R programs, and oversee CROs to deliver high-quality results for regulatory submissions and studies.