Remote Principal Statistical Programmer: SAS/R, CDISC

Belhar Islamic Primary School; Cape Town; A distancia; ZAR 1.990.000 - 3.150.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming efforts in clinical development, delivering SDTM/ADaM datasets, tables, listings and graphs. The role requires senior-level SAS programming, experience with CDISC standards, and collaboration with CROs and internal teams.

The candidate will work independently with minimal supervision, support regulatory submissions, and ensure data quality and compliance across studies in a multinational setting.

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma with data development experience.
• Expert SAS programming; CDISC (SDTM/ADaM/Define.xml) knowledge; regulatory submissions.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality targets.
• Support preparation of clinical study reports, regulatory submissions, DSUR.
• Adhere to FDA/ICH regulations and GCP for electronic submissions.
• Develop and validate standards for programming tools and macros.
• Contribute to CRF creation, edit checks, validation plans.

Conocimientos

Independent work

Leadership

Excellent communication

Educación

Bachelor's degree in computer science / data science / mathematics / statistics

Herramientas

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming efforts in clinical development, delivering SDTM/ADaM datasets, tables, listings and graphs. The role requires senior-level SAS programming, experience with CDISC standards, and collaboration with CROs and internal teams.

The candidate will work independently with minimal supervision, support regulatory submissions, and ensure data quality and compliance across studies in a multinational setting.