Senior Principal Statistical Programmer (SAS + R) — Remote

Placements24; Upington; Teletrabalho; ZAR 1 994 000 - 2 824 000; Tempo integral

Resumo da oferta

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) for remote work embedded with a global pharmaceutical client. You’ll lead programming activities, ensure data are delivered with high quality, and work with statistics to support trials and regulatory submissions.

You will implement SDTM/ADaM, review define.xml, manage datasets and listings, and oversee CRO deliverables to meet timelines while following FDA/ICH guidelines.

Qualificações

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in biotech/pharma clinical development biometrics.
• Expert SAS programming with SDTM/ADaM define.xml experience.
• Experience supporting regulatory submissions and working with FDA/ICH guidelines.
• Strong communication and independent work capabilities.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results and validate SAS/R programs.
• Oversee CROs’ programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports and regulatory submissions.
• Contribute to programming standards, CRFs, and data validation plans.
• Collaborate with internal/external partners to achieve project goals.
• Review SOPs and work instructions related to statistical programming.

Conhecimentos

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Leadership

Independent work

Formação académica

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

Ferramentas

Unix/Linux

Git

Python

Shiny

Descrição da oferta de emprego

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) for remote work embedded with a global pharmaceutical client. You’ll lead programming activities, ensure data are delivered with high quality, and work with statistics to support trials and regulatory submissions.

You will implement SDTM/ADaM, review define.xml, manage datasets and listings, and oversee CRO deliverables to meet timelines while following FDA/ICH guidelines.