Senior Principal Statistical Programmer: SAS + R (Remote)

The Door Talent; Asturias; A distancia; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team embedded with a pharmaceutical client. You will develop SDTM/ADaM specifications and SAS/R programs for trials in various therapeutic areas.

The role requires 7+ years of experience, strong SAS and CDISC expertise, and familiarity with FDA/ICH regulations. You will oversee CRO programming, support regulatory submissions, and contribute to standardization efforts while acting with autonomy

Formación

• Bachelor's degree in CS, data science, mathematics, or statistics.
• 7+ years in statistical programming on biotech/pharma clinical development.
• Exceptional SAS programming with SDTM/ADaM/Define.xml experience.
• Familiarity with regulatory submissions and FDA/ICH regulations.
• Strong communication and leadership abilities.
• Ability to work independently.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs tailored to clinical programs’ needs.
• Oversee CROs' programming deliverables across studies to meet timelines.
• Support creation of CSRs, regulatory submissions, publications, and DSURs.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and partners to meet project goals.
• Draft SOPs and work instructions for statistical programming practices.

Conocimientos

SAS programming

CDISC standards

Independent worker

Leadership

Communication

Educación

BSc Computer Science

BSc Data Science

BSc Mathematics/Statistics

Herramientas

R

Python

Java

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team embedded with a pharmaceutical client. You will develop SDTM/ADaM specifications and SAS/R programs for trials in various therapeutic areas.

The role requires 7+ years of experience, strong SAS and CDISC expertise, and familiarity with FDA/ICH regulations. You will oversee CRO programming, support regulatory submissions, and contribute to standardization efforts while acting with autonomy