Principal Statistical Programmer (SAS/R) - Remote

Crazy Labs Ltd.; Valladolid; Remote; EUR 60,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with a sponsor-dedicated role embedded within a pharmaceutical client. You will lead SDTM/ADaM specification work, develop SAS and R programs, and oversee CRO deliverables to ensure high-quality data summaries for regulatory submissions.

You will operate with minimal supervision, drive data reporting, and support clinical study reports and DSURs, while adhering to FDA regulations and GCP 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 including developing, validating, and maintaining SAS and/or R programs
• Oversee CRO's statistical programming deliverables for multiple clinical studies to ensure high quality and timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Follow FDA regulations and GCP for electronic submissions
• Contribute to the creation, maintenance, and validation of standards for programming tools and outputs
• Develop CRFs, edit check specifications, and data validation plans
• Provide review of data transfer specifications for external vendor data
• Collaborate with internal and external functions to meet project timelines

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with a sponsor-dedicated role embedded within a pharmaceutical client. You will lead SDTM/ADaM specification work, develop SAS and R programs, and oversee CRO deliverables to ensure high-quality data summaries for regulatory submissions.

You will operate with minimal supervision, drive data reporting, and support clinical study reports and DSURs, while adhering to FDA regulations and GCP guidelines.