Principal Statistical Programmer (Remote) SAS/R

Placements24; East London; A distancia; ZAR 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to be embedded with a pharmaceutical client, applying SAS and R to create SDTM/ADaM, define.xml, and complex listings across studies.

You will oversee CRO programmers, deliver high-quality programming outputs, support regulatory submissions, and ensure compliance with FDA/ICH guidelines; 7+ years of experience required. This is a remote, sponsor-dedicated role with global collaboration.

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma with clinical development biometrics.
• Exceptional SAS programming and CDISC standards experience.
• Experience supporting regulatory submissions and interactions with FDA/authorities.
• Independent work style with strong communication and leadership.

Responsabilidades

• Generate SDTM/ADaM specs, datasets, reviewer's guides and define.xml for studies.
• Develop SAS programs for datasets, listings, tables and graphs; collaborate on stats.
• Deliver high-quality programming outputs; validate and maintain SAS/R programs.
• Oversee CROs' deliverables to meet timelines and quality standards.
• Support preparation of CSRs, regulatory submissions, DSURs and analyses.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Create and maintain standards, CRFs, edit checks, and data validation plans.
• Collaborate with internal/external partners to meet project goals.
• Draft SOPs and Work Instructions related to statistical programming.

Conocimientos

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulatory knowledge

Leading CRO programming

Communication

R programming

Data analysis

GCP familiarity

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 to be embedded with a pharmaceutical client, applying SAS and R to create SDTM/ADaM, define.xml, and complex listings across studies.

You will oversee CRO programmers, deliver high-quality programming outputs, support regulatory submissions, and ensure compliance with FDA/ICH guidelines; 7+ years of experience required. This is a remote, sponsor-dedicated role with global collaboration.