Senior Principal Statistical Programmer - SAS + R (Remote)

Hoteljobs

Cape Town

A distancia

ZAR 1.495.000 - 2.492.000

Jornada completa

Hace 10 días

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Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with a pharmaceutical client. This remote role offers autonomy and ownership within a sponsor-dedicated program.

You will generate SDTM/ADaM specs, develop SAS and R programs, oversee CRO programmers, and support regulatory submissions and study reports in line with FDA/ICH guidelines. The ideal candidate has a Bachelor's degree in a quantitative field, 7+ years of experience, deep CDISC knowledge, and

Formación

  • Bachelor's degree in CS/Data Science/Math/Statistics.
  • 7+ years of experience as Statistical Programmer in Biotech/Pharma biometrics.
  • SAS programming skills with CDISC SDTM/ADaM; FDA/ICH regulatory knowledge.
  • Experience supporting regulatory submissions and CRO oversight.

Responsabilidades

  • Generate SDTM, ADaM specs and define.xml for multiple studies.
  • Develop SAS and R programs for datasets, listings, tables and graphs.
  • Oversee CRO programmers to ensure timely, high-quality deliverables.
  • Contribute to CSR, regulatory submissions, DSUR and exploratory analyses.
  • Follow FDA regulations and GCP for clinical trial data reporting.

Conocimientos

SAS programming
CDISC SDTM/ADaM
Regulatory submissions
Independent worker
Leadership
Communication skills
R
Python

Educación

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

Herramientas

R
Python

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with a pharmaceutical client. This remote role offers autonomy and ownership within a sponsor-dedicated program.

You will generate SDTM/ADaM specs, develop SAS and R programs, oversee CRO programmers, and support regulatory submissions and study reports in line with FDA/ICH guidelines. The ideal candidate has a Bachelor's degree in a quantitative field, 7+ years of experience, deep CDISC knowledge, and

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