Principal Statistical Programmer (SAS + R) Remote

Afgri Group; South Africa; A distancia; ZAR 900.000 - 1.400.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a fully remote role, embedded with a global pharmaceutical client.

You will lead SAS-based data handling, SDTM/ADaM specifications, and complex analyses while collaborating with CROs to ensure timely, high-quality submissions. The role demands 7+ years in statistical programming, deep CDISC knowledge, and experience with regulatory submissions.

Formación

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development.
• Expert in SAS programming and CDISC standards (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions with FDA/ICH guidelines.
• Ability to work independently with strong communication and leadership.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables and graphs.
• Ensure high-quality programming outputs and oversee CRO deliverables.
• Support clinical study reports, regulatory submissions and DSUR.
• Collaborate with CROs and vendors to meet timelines.
• Create and validate standards for programming tools and macros.
• Contribute to CRFs, edit checks, and data validation plans.
• Review data transfer specifications for external data.
• Ensure compliance with FDA regulations and GCP.
• Draft SOPs and work instructions for programming practices.

Conocimientos

SAS programming

CDISC standards

Regulatory submissions

Independent worker

Leadership

Communication

Educación

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

Herramientas

SAS

R

Python

Java

Shiny

Unix/Linux

git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a fully remote role, embedded with a global pharmaceutical client.

You will lead SAS-based data handling, SDTM/ADaM specifications, and complex analyses while collaborating with CROs to ensure timely, high-quality submissions. The role demands 7+ years in statistical programming, deep CDISC knowledge, and experience with regulatory submissions.