Principal Statistical Programmer (SAS & R) – Remote

Aireko Services & Installation; Jerez de la Frontera; Remote; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client, delivering SDTM/ADaM specifications, datasets, tables, and graphs. You will oversee CRO programming deliverables, ensure high-quality analyses, and support regulatory submissions in a highly autonomous environment.

The role emphasizes development and validation of SAS and R programs, adherence to GCP and FDA guidelines, and collaboration across study teams within Cytel's

Qualifications

• 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

Responsibilities

• Oversee CROs' statistical programming deliverables to ensure quality and timelines
• Develop and validate SAS and R programs for SDTM/ADaM datasets and outputs
• Create and maintain reporting specifications and define.xml files
• Support preparation of CSRs, regulatory submissions and exploratory analyses
• Ensure compliance with FDA GCP and electronic submission guidelines

Skills

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client, delivering SDTM/ADaM specifications, datasets, tables, and graphs. You will oversee CRO programming deliverables, ensure high-quality analyses, and support regulatory submissions in a highly autonomous environment.

The role emphasizes development and validation of SAS and R programs, adherence to GCP and FDA guidelines, and collaboration across study teams within Cytel's