Senior Principal Statistical Programmer (Remote) - SAS & R

Moniepoint Inc.; Vitoria; A distancia; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with one of our pharmaceutical clients. You will be the sponsor programmer, leading programming activities across SDTM/ADaM, developing SAS and R code, and delivering high-quality data outputs for regulatory submissions.

You will oversee CRO programmers, contribute to trial reports and DSURs, and ensure FDA/GCP compliance. This role requires independence, strong communication, and hands-on standardization of data

Formación

• Senior-level statistical programming experience in drug development.
• Proven ability to deliver SAS and R programs for trials and regulatory submissions.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development programs' needs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and exploratory analyses.
• Understand and follow FDA regulations and guidelines for submissions (GCP).
• Contribute to creation/maintenance of standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs and software vendors to meet project timelines.

Conocimientos

SAS programming

R programming

Clinical trial programming

SDTM/ADaM

Regulatory submissions

Herramientas

SAS

R

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with one of our pharmaceutical clients. You will be the sponsor programmer, leading programming activities across SDTM/ADaM, developing SAS and R code, and delivering high-quality data outputs for regulatory submissions.

You will oversee CRO programmers, contribute to trial reports and DSURs, and ensure FDA/GCP compliance. This role requires independence, strong communication, and hands-on standardization of data