Principal Statistical Programmer (SAS + R) Remote

Ethos; Nava; Remote; EUR 70,000 - 100,000; Full time

Job summary

Ethos is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated program, working remotely with Cytel support behind you. The role focuses on clinical data programming across multiple studies, ensuring high-quality outputs and adherence to regulatory standards.

You will generate SDTM/ADaM specifications, develop SAS and R programs, oversee CROs, and contribute to regulatory submissions and study reports, while following FDA guidelines and industry best practices.

Qualifications

• Experience in statistical programming for clinical trials.
• Proficiency in SAS and R programming for datasets, listings, tables, and graphs.
• Ability to oversee CROs and ensure timely, high-quality deliverables.

Responsibilities

• Generate SDTM and ADaM specifications and define.xml files.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver SAS and R programs for clinical development programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Adhere to FDA regulations and GCP for reporting trial data.
• Contribute to standards for programming tools and macros.
• Develop CRFs and data validation plans; provide data transfer specs.
• Collaborate with internal/external partners to meet project goals.

Skills

SAS

R

Clinical data analyses

Tools

SDTM

ADaM

Regulatory submissions

Job description

Ethos is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated program, working remotely with Cytel support behind you. The role focuses on clinical data programming across multiple studies, ensuring high-quality outputs and adherence to regulatory standards.

You will generate SDTM/ADaM specifications, develop SAS and R programs, oversee CROs, and contribute to regulatory submissions and study reports, while following FDA guidelines and industry best practices.