Senior Principal Statistical Programmer (SAS and R)-Remote

Csu-Digital

Las Palmas de Gran Canaria

Remote

EUR 70,000 - 110,000

Full time

5 days ago

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Job summary

Cytel is seeking a Senior/Principal Statistical Programmer for a remote role dedicated to a pharmaceutical client. You will work under minimal supervision, delivering SDTM/ADaM specifications, complex listings, and graphs, while maintaining high-quality outputs.

You will oversee CRO programmers and ensure adherence to regulatory guidelines for electronic submissions. The role emphasizes expertise in SAS and R programming within clinical development programs, with collaboration across teams to

Qualifications

Senior-level experience as a Statistical Programmer in clinical development.
Proficient in generating SDTM/ADaM specifications and DEFINE.xml.
Ability to oversee CRO programming deliverables and ensure data quality.

Responsibilities

Generate SDTM and ADaM datasets, specifications, define.xml, and reviewer's guides for studies.
Develop SAS programs to produce datasets, listings, tables, and graphs.
Deliver high-quality programming outputs and validate SAS and R programs for development programs.
Oversee CROs' programming deliverables to meet timelines and quality standards.
Support preparation of clinical study reports and regulatory submissions.
Follow FDA regulations and guidelines for electronic submissions.
Contribute to standards for programming tools, outputs, and macros.
Develop CRFs, edit checks, and data validation plans as needed.
Collaborate with internal and external partners to meet project goals.