Principal Statistical Programmer (Remote) — SAS + R Expert

Farmacia Con Atención Al Usuario Personalizada; Murcia; Remoto; EUR 107.000 - 161.000; Tempo pieno

Descrizione del lavoro

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R for remote work within our sponsor-dedicated team. You will lead statistical programming for multiple clinical trials, implement SDTM/ADaM, and oversee CROs to ensure timely, high-quality data deliverables and regulatory submissions.

You will work independently with minimal supervision, applying FDA/ICH guidelines, contributing to CRFs, data transfer specs, and SOPs, while mentoring juniors in a collaborative environment.

Competenze

• Bachelor's degree in computer science, data science, mathematics, or statistics (or equivalent).
• 7+ years as Statistical Programmer on Biotech/Pharma Clinical Development Biometrics team or similar.
• Exceptional SAS programming skills for clinical development.
• CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulations familiarity.

Mansioni

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Oversee CRO programmers to ensure high-quality deliverables per timelines.
• Support clinical study reports, regulatory submissions, publications and DSUR.

Conoscenze

SAS programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Leadership

Independent work

Communication

Formazione

Bachelor's degree in computer science, data science, mathematics, or statistics

Strumenti

R

Python

Unix/Linux

Git

Shiny

Descrizione del lavoro

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R for remote work within our sponsor-dedicated team. You will lead statistical programming for multiple clinical trials, implement SDTM/ADaM, and oversee CROs to ensure timely, high-quality data deliverables and regulatory submissions.

You will work independently with minimal supervision, applying FDA/ICH guidelines, contributing to CRFs, data transfer specs, and SOPs, while mentoring juniors in a collaborative environment.