Principal Statistical Programmer - SAS/R, Remote

Norconsulting Global Recruitment; Marbella; Remote; EUR 60,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to be fully embedded with a global pharmaceutical client, working remotely with Cytel support behind you.

In this role you will develop SDTM/ADaM specifications, write SAS and R programs, review CRO deliverables, contribute to study reports and regulatory submissions, and ensure high-quality data analyses in line with 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 and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to be fully embedded with a global pharmaceutical client, working remotely with Cytel support behind you.

In this role you will develop SDTM/ADaM specifications, write SAS and R programs, review CRO deliverables, contribute to study reports and regulatory submissions, and ensure high-quality data analyses in line with FDA guidelines.