Senior Principal Statistical Programmer - SAS/R (Remote)

Devoteam Spain; Madrid; Remote; EUR 70,000 - 105,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to support pharmaceutical clients within the FSP Services unit. You will develop SDTM/ADaM specs and deliver high-quality programming for multiple studies.

The role involves overseeing CRO programmers, delivering listings, tables, and graphs, and contributing to regulatory submissions and final reports while adhering to FDA guidelines.

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 (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• 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

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to support pharmaceutical clients within the FSP Services unit. You will develop SDTM/ADaM specs and deliver high-quality programming for multiple studies.

The role involves overseeing CRO programmers, delivering listings, tables, and graphs, and contributing to regulatory submissions and final reports while adhering to FDA guidelines.