Senior Principal Statistical Programmer SAS/R (Remote)

Domestiko.Com; Ibiza; Remote; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program embedded with one of our pharmaceutical clients. You will lead programming efforts and oversee CROs to ensure high-quality data deliverables.

In this senior role you will develop SDTM/ADaM specifications, write SAS and R programs, and support study reports and regulatory submissions in a compliant environment.

Qualifications

• Senior/Principal Statistical Programmer with clinical trial programming experience.
• Experience coordinating CROs and delivering high-quality data.
• Strong knowledge of SDTM/ADaM specifications and regulatory expectations.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality SAS and R programs tailored to clinical development needs
• Oversee CROs' statistical programming deliverables across studies to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Understand and follow FDA regulations and good clinical practice for electronic submissions
• Contribute to standardization of programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review of data transfer specifications for external vendor data
• Collaborate with internal and external partners to meet project goals
• Provide review and guidance as needed

Skills

SAS

R programming

SDTM

ADaM

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program embedded with one of our pharmaceutical clients. You will lead programming efforts and oversee CROs to ensure high-quality data deliverables.

In this senior role you will develop SDTM/ADaM specifications, write SAS and R programs, and support study reports and regulatory submissions in a compliant environment.