Principal Statistical Programmer (SAS + R) - Remote

La Casa de las Carcasas France; Cáceres; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a sponsor client. You will lead statistical programming for clinical development programs, implement SDTM/ADaM specifications, and supervise CRO programmers to ensure high-quality data deliverables.

You will develop SAS and R programs, generate complex listings, tables, and figures, and support regulatory submissions while adhering to FDA/GCP guidelines.

Qualifications

• Senior statistical programmer with extensive clinical development experience.
• Experience overseeing CRO programmers.
• Ability to develop SDTM/ADaM specifications and define.xml.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, listings, tables, and graphs
• Deliver high-quality statistical programming results with SAS and/or R
• Oversee CRO's statistical programming deliverables to meet timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, and exploratory analyses
• Understand and follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide review

Tools

SAS

R

SDTM

ADaM

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a sponsor client. You will lead statistical programming for clinical development programs, implement SDTM/ADaM specifications, and supervise CRO programmers to ensure high-quality data deliverables.

You will develop SAS and R programs, generate complex listings, tables, and figures, and support regulatory submissions while adhering to FDA/GCP guidelines.