Remote Principal Statistical Programmer (SAS + R)

Ingeteam; Badajoz; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven pharmacovigilance projects with a global pharmaceutical client. You will lead programming activities, develop SDTM/ADaM datasets, and deliver complex listings, tables and graphs using SAS and R, with high autonomy and collaboration with CROs.

The role emphasizes independence, regulatory compliance (GCP/FDA guidelines), and contribution to standards while supporting regulatory submissions and study

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 including SAS and/or R programs
• Oversee CRO's statistical programming deliverables to ensure high quality and timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses
• Understand and follow FDA regulations affecting reporting of clinical trial data
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide review

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven pharmacovigilance projects with a global pharmaceutical client. You will lead programming activities, develop SDTM/ADaM datasets, and deliver complex listings, tables and graphs using SAS and R, with high autonomy and collaboration with CROs.

The role emphasizes independence, regulatory compliance (GCP/FDA guidelines), and contribution to standards while supporting regulatory submissions and study