Senior Statistical Programmer (SAS + R) - Remote

Estivill-Professionals-Associats; Tarragona; Remote; EUR 65,000 - 95,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated projects. You will implement reporting and analysis activities for Sponsor clinical trials, overseeing CRO programmers to ensure quality and on-time delivery.

The position requires deep SAS and R programming experience, expertise in SDTM/ADaM, and familiarity with FDA regulations and GCP for submissions. You will collaborate with cross-functional teams across studies.

Qualifications

• Senior statistical programmer with extensive experience in clinical development.
• Proficient in SAS and R programming and data analysis.
• Experience overseeing CRO programming activities and deliverables.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guide and define.xml files for multiple studies.
• Develop SAS programs which generate datasets, complex listings, tables and graphs in collaboration with statisticians.
• Deliver high-quality statistical programming results across clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Understand and follow FDA regulations and GCP for electronic submissions.
• Contribute to creation and validation of standards for programming tools and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Review and/or author data transfer specifications for external vendor data.
• Collaborate with internal/external functions to meet timelines and goals.
• Review and/or author SOPs and work instructions for programming practices.

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated projects. You will implement reporting and analysis activities for Sponsor clinical trials, overseeing CRO programmers to ensure quality and on-time delivery.

The position requires deep SAS and R programming experience, expertise in SDTM/ADaM, and familiarity with FDA regulations and GCP for submissions. You will collaborate with cross-functional teams across studies.