Principal Statistical Programmer (SAS/R) — Remote

Ethos; Islas Baleares; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to be embedded with a pharmaceutical client in a fully remote role. You will lead programming activities across SDTM/ADaM, develop complex tables, listings, and graphs, and ensure high-quality data outputs for regulatory submissions and studies.

You will manage CRO deliverables, maintain standards, and contribute to study reports, DSURs, and exploratory analyses while aligning with FDA guidelines and good clinical practice.

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 (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs\' needs
• Participate in overseeing CRO\'s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to be embedded with a pharmaceutical client in a fully remote role. You will lead programming activities across SDTM/ADaM, develop complex tables, listings, and graphs, and ensure high-quality data outputs for regulatory submissions and studies.

You will manage CRO deliverables, maintain standards, and contribute to study reports, DSURs, and exploratory analyses while aligning with FDA guidelines and good clinical practice.