Senior Statistical Programmer (SAS/R) - Remote

Oficina-De-Treball-Del-Soc; Tarragona; Remote; EUR 60,000 - 90,000; Full time

Job summary

Cytel in Spain is seeking a Senior/Principal Statistical Programmer (Remote) to work on clinical development programs across therapeutic areas with autonomy and ownership.

You will deliver SDTM/ADaM specs, write SAS and R programs, generate complex tables and listings, and oversee CRO programmers to maintain timelines.

You will support regulatory submissions, study reports, and exploratory analyses while following FDA guidelines and industry best practices.

Qualifications

• Senior/Principal Statistical Programmer with strong experience in clinical development.
• Experience in SDTM/ADaM specifications and programming in SAS and R.
• Ability to oversee CRO programmers and ensure high-quality deliverables on timelines.

Responsibilities

• Generate SDTM, ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality SAS and R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Understand FDA regulations affecting electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external data.
• Collaborate with CROs, vendors and partners to meet project goals.
• Draft SOPs and Work Instructions for statistical programming practices.

Skills

SAS

R

Statistical programming

Clinical trials

Job description

Cytel in Spain is seeking a Senior/Principal Statistical Programmer (Remote) to work on clinical development programs across therapeutic areas with autonomy and ownership.

You will deliver SDTM/ADaM specs, write SAS and R programs, generate complex tables and listings, and oversee CRO programmers to maintain timelines.

You will support regulatory submissions, study reports, and exploratory analyses while following FDA guidelines and industry best practices.