Principal Statistical Programmer – SAS & R (Remote)

Wesbank; Polokwane; Teletrabalho; ZAR 1 994 000 - 2 991 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Remote work

Global collaboration

Resumo da oferta

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote role dedicated to a sponsor.

You will independently lead programming activities across clinical development, generating SDTM/ADaM datasets, define.xml, and complex tables/graphs, while guiding CROs to ensure high-quality, timely submissions. You will leverage extensive SAS and CDISC experience, support regulatory submissions, and work with FDA/regulatory authorities as needed, contributing to global trial success from a

Qualificações

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years experience as Statistical Programmer in Biotech/Pharma clinical development.
• SAS programming skills and clinical development experience.
• CDISC SDTM/ADaM/Define.xml, terminology, regulatory knowledge.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently; strong communication and leadership.

Responsabilidades

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

Conhecimentos

SAS programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Communication skills

Leadership

R

Python

Java

Shiny

Unix/Linux

Git

Formação académica

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

Ferramentas

SAS software

Descrição da oferta de emprego

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote role dedicated to a sponsor.

You will independently lead programming activities across clinical development, generating SDTM/ADaM datasets, define.xml, and complex tables/graphs, while guiding CROs to ensure high-quality, timely submissions. You will leverage extensive SAS and CDISC experience, support regulatory submissions, and work with FDA/regulatory authorities as needed, contributing to global trial success from a