Senior Statistical Programmer (SAS/R) — Remote, Bilingual

Tebi Tecnologia; Caspe; Remote; EUR 70,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to be fully embedded with a leading pharmaceutical client, with Cytel support behind you, driving data analysis and reporting for sponsor studies.

You will develop SDTM/ADaM specifications, datasets, listings and define.xml, oversee CROs, and contribute to regulatory submissions while ensuring FDA/ICH guideline compliance. Collaboration across functional teams is essential.

Qualifications

• Requires independent work style and ability to take ownership of programming deliverables.
• Strong analytical skills and attention to data quality and documentation.
• Experience with regulatory submissions and FDA/ICH guidelines is highly desirable.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphics.
• Deliver high-quality programming outputs tailored to clinical development needs.
• Oversee CROs' programming deliverables to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions, publications, and DSURs.
• Understand and apply FDA regulations for electronic submissions and GCP guidance.
• Contribute to standards and templates for programming tools, outputs, and macros.
• Assist in CRF development, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal/external partners to achieve project goals and timelines.
• Draft SOPs and work instructions for statistical programming practices.

Skills

Independence

Analytical thinking

Regulatory liaison experience

Education

Bachelor's degree in computer science, statistics, or related field

Tools

SAS

R

CDISC SDTM/ADaM

Define.xml

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to be fully embedded with a leading pharmaceutical client, with Cytel support behind you, driving data analysis and reporting for sponsor studies.

You will develop SDTM/ADaM specifications, datasets, listings and define.xml, oversee CROs, and contribute to regulatory submissions while ensuring FDA/ICH guideline compliance. Collaboration across functional teams is essential.