Remote Principal Statistical Programmer (SAS + R)

Goldman Tech Resourcing; South Africa; A distancia; ZAR 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to be fully embedded with a pharmaceutical client, delivering SDTM/ADaM outputs and regulatory-ready reports. You will work independently, providing expert SAS and R programming support and oversee CROs to ensure high-quality deliverables.

The role requires extensive CDISC experience, FDA submission familiarity, and strong leadership and communication skills, with a fully remote workload and global collaboration.

Formación

• 7+ years as Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Aptitude in SAS programming within a clinical development environment.
• CDISC SDTM/ADaM/Define.xml experience and medical terminology knowledge.
• Experience supporting regulatory submissions and FDA interactions.
• Ability to work independently.
• Strong written and verbal communication and leadership.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results with SAS and/or R.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.

Conocimientos

SAS programming

R programming

CDISC standards

Regulatory submissions

Independent work

Communication skills

Leadership

Educación

Bachelor's degree in CS/Data Science/Math/Stats

Herramientas

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to be fully embedded with a pharmaceutical client, delivering SDTM/ADaM outputs and regulatory-ready reports. You will work independently, providing expert SAS and R programming support and oversee CROs to ensure high-quality deliverables.

The role requires extensive CDISC experience, FDA submission familiarity, and strong leadership and communication skills, with a fully remote workload and global collaboration.