Principal Statistical Programmer (SAS + R) – Remote

Crazy Labs Ltd.; Huelva; Remote; EUR 90,000 - 120,000; Full time

Job summary

Crazy Labs Ltd. is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated role for a global pharmaceutical client.

The role involves independent programming in SAS and R, SDTM/ADaM development, and collaboration with CROs to ensure high-quality data outputs for regulatory submissions. The candidate will contribute to study reports, DSURs, and exploratory analyses while adhering to FDA guidelines and GCP.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables and graphs
• Deliver high-quality statistical programming results using SAS and/or R
• Oversee CRO programming deliverables to meet pre-specified timelines
• Support preparation of clinical study reports, regulatory submissions and DSURs
• Follow FDA regulations for electronic submissions and GCP
• Contribute to standards for programming tools, outputs and macros
• Develop CRFs, edit check specs and data validation plans
• Review and/or author data transfer specs for external vendors
• Collaborate with CROs, vendors and partners to meet project goals

Tools

SAS

R

Job description

Crazy Labs Ltd. is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated role for a global pharmaceutical client.

The role involves independent programming in SAS and R, SDTM/ADaM development, and collaboration with CROs to ensure high-quality data outputs for regulatory submissions. The candidate will contribute to study reports, DSURs, and exploratory analyses while adhering to FDA guidelines and GCP.