Principal Statistical Programmer (Remote) - SAS + R

Saeta Yield SA; Quirós; Remote; EUR 55,000 - 85,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven clinical trials. The role involves handling SDTM/ADaM specifications, datasets, and create detailed reporting artifacts with SAS and R.

You will lead CRO programming deliverables and ensure timely, high-quality outputs for regulatory submissions. The candidate will support clinical study reports, DSURs, and exploratory analyses while adhering to FDA regulations, GCP, and electronic submission

Qualifications

• Senior statistical programmer with clinical trial experience and CRO oversight.
• Experience developing SDTM/ADaM specifications and datasets.
• Knowledge of FDA regulations, GCP, and electronic submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results with SAS and/or R programs.
• Oversee CRO's statistical programming deliverables for multiple studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses.
• Ensure compliance with 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.

Skills

SAS

R

Clinical programming

SDTM

ADaM

CRO oversight

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven clinical trials. The role involves handling SDTM/ADaM specifications, datasets, and create detailed reporting artifacts with SAS and R.

You will lead CRO programming deliverables and ensure timely, high-quality outputs for regulatory submissions. The candidate will support clinical study reports, DSURs, and exploratory analyses while adhering to FDA regulations, GCP, and electronic submission