Programador Estadístico Senior – Clínico (Remoto)

Profile Software Services; Ceuta; Remote; EUR 98,000 - 143,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated role, fully embedded with a global pharmaceutical client. You will deliver SDTM/ADaM specs and lead programming for clinical trials in a remote setting.

You will develop SAS and R programs for datasets, listings, tables, and graphs, supervise CRO programmers, support regulatory submissions, and ensure high-quality outputs in line with FDA guidelines.

Qualifications

• Experience in statistical programming for clinical trials.
• Ability to develop SDTM/ADaM specifications and datasets.
• Experience with regulatory submissions and CRO coordination.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data
• 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

Skills

SAS programming

R programming

CRO oversight

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated role, fully embedded with a global pharmaceutical client. You will deliver SDTM/ADaM specs and lead programming for clinical trials in a remote setting.

You will develop SAS and R programs for datasets, listings, tables, and graphs, supervise CRO programmers, support regulatory submissions, and ensure high-quality outputs in line with FDA guidelines.