Principal Statistical Programmer (SAS/R) — Remote Lead

Procesia; La Coruña; Remote; EUR 55,000 - 90,000; Full time

Job summary

Procesia is seeking a Senior/Principal Statistical Programmer with expertise in SAS and R for remote global clinical development projects. You will generate SDTM/ADaM outputs, oversee CRO programming deliverables, ensure regulatory-compliant submissions, and contribute to study reports and data documentation across several therapeutic areas.

The role reports to the Biostatistics and Programming leadership and emphasizes independent work, high-quality deliverables, and strong collaboration with

Qualifications

• Senior statistical programmer with extensive clinical trial experience.
• Experience delivering SDTM/ADaM outputs and reports.
• Knowledge of FDA GCP guidelines and electronic submissions.

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, validating SAS and/or R programs
• Oversee CRO's programming deliverables to meet timelines
• Support preparation of study reports, regulatory submissions, publications, and DSURs
• Follow FDA regulations affecting reporting of trial data and electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review

Skills

SAS programming

R programming

Clinical data analysis

Statistical programming

Regulatory submissions

Tools

SAS

R

Job description

Procesia is seeking a Senior/Principal Statistical Programmer with expertise in SAS and R for remote global clinical development projects. You will generate SDTM/ADaM outputs, oversee CRO programming deliverables, ensure regulatory-compliant submissions, and contribute to study reports and data documentation across several therapeutic areas.

The role reports to the Biostatistics and Programming leadership and emphasizes independent work, high-quality deliverables, and strong collaboration with