Principal Statistical Programmer (Remote) – SAS & R Expert

Thermofisher Scientific; Santa Cruz de Tenerife; A distancia; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior/Principal Statistical Programmer for a fully remote role. You will work on clinical development programs, implementing SDTM/ADaM standards and delivering high-quality analyses and reports. You will coordinate with CROs and sponsors to ensure timely delivery and compliance with regulatory guidelines.

The role requires extensive experience in SAS and R, strong knowledge of SDTM/ADaM, and the ability to work independently with minimal supervision.

Formación

• Extensive experience in clinical trial programming.
• Proficient in SAS and R for analysis and reporting.
• Strong knowledge of SDTM/ADaM data structures.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality results tailored to clinical development needs.
• Oversee CRO programmers to meet timelines and quality targets.
• Support preparation of study reports and regulatory submissions.
• Follow FDA and GxP guidelines for electronic submissions.
• Create standards for tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review data transfer specifications for external vendors.
• Collaborate with internal/external partners to hit milestones.

Conocimientos

Statistical programming

SDTM

ADaM

SAS

R

Clinical trials

Herramientas

GxP familiarity

Descripción del empleo

Thermo Fisher Scientific is seeking a Senior/Principal Statistical Programmer for a fully remote role. You will work on clinical development programs, implementing SDTM/ADaM standards and delivering high-quality analyses and reports. You will coordinate with CROs and sponsors to ensure timely delivery and compliance with regulatory guidelines.

The role requires extensive experience in SAS and R, strong knowledge of SDTM/ADaM, and the ability to work independently with minimal supervision.