Principal Statistical Programmer (SAS + R) – Remote

Hoteljobs; South Africa; A distancia; ZAR 1.994.000 - 2.991.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role. You will work with one global pharmaceutical client, delivering high-quality SDTM/ADaM work, oversee CRO programming, and drive regulatory submissions with minimal supervision.

We require 7+ years in biotech/pharma programming, strong SAS and CDISC expertise, and excellent communication and leadership skills. This role offers global collaboration and opportunity to influence trial data standards.

Formación

• Minimum bachelor-level degree in CS, data science, math, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma with drug development experience.
• Expert SAS programming and CDISC standards experience (SDTM/ADaM/Define.xml).
• Experience with regulatory submissions and FDA/ICH guidelines.

Responsabilidades

• Develop SDTM/ADaM specs, datasets, define.xml and reviewer’s guides.
• Write SAS programs to produce datasets, listings, tables, and graphs.
• Deliver SAS/R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support regulatory submissions, study reports, DSURs, and analyses.
• Follow GCP and FDA submission guidelines; develop standards and macros.
• Collaborate with CROs and vendors to meet project goals.
• Prepare data transfer specs and SOPs/work instructions.

Conocimientos

SAS programming

R

CDISC SDTM/ADaM

Define.xml

FDA/ICH regulation knowledge

Independent work

Leadership communication

Educación

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Herramientas

SAS

R

Python

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role. You will work with one global pharmaceutical client, delivering high-quality SDTM/ADaM work, oversee CRO programming, and drive regulatory submissions with minimal supervision.

We require 7+ years in biotech/pharma programming, strong SAS and CDISC expertise, and excellent communication and leadership skills. This role offers global collaboration and opportunity to influence trial data standards.