Remote Principal Statistical Programmer (SAS + R)

Sargadelos; Marín; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-integrated program. You will work on clinical development programs across therapeutic areas, independently guiding CRO programmers and delivering high-quality SAS and R analyses for trials.

You will generate SDTM/ADaM specifications and define.xml, create datasets and complex tables, and contribute to regulatory submissions and study reports while adhering to FDA guidelines and good clinical practice.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to create datasets, listings, tables and graphs
• Deliver high-quality statistical programming results with SAS and/or R
• Oversee CRO's programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses
• Understand and follow FDA regulations for reporting clinical trial data
• 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 (Remote) to join a sponsor-integrated program. You will work on clinical development programs across therapeutic areas, independently guiding CRO programmers and delivering high-quality SAS and R analyses for trials.

You will generate SDTM/ADaM specifications and define.xml, create datasets and complex tables, and contribute to regulatory submissions and study reports while adhering to FDA guidelines and good clinical practice.