Remote Principal Statistical Programmer (SAS + R)

Placements24

Polokwane

Remote

ZAR 900,000 - 1,500,000

Full time

13 days ago

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Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a major pharmaceutical sponsor. You will lead programming activities across SDTM/ADaM, define.xml, and related outputs while guiding CROs to deliver high-quality results.

The role requires 7+ years in biostatistics programming and strong FDA-regulatory experience. You will collaborate with statisticians and cross-functional teams to ensure compliant, timely submissions and robust data analyses across

Qualifications

Bachelor’s degree in CS/Data Science/Math/Statistics or related field.
7+ years of experience as Statistical Programmer in Biotech/Pharma clinical development Biometrics team.
Exceptional SAS programming skills and CDISC SDTM/ADaM expertise.
Experience supporting regulatory submissions and interactions with FDA/NA regulatory authorities.

Responsibilities

Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
Develop SAS programs to generate datasets, listings, tables and graphs; ensure quality and reproducibility.
Deliver high-quality programming results including developing, validating, and maintaining SAS and/or R programs.
Oversee CRO programmers’ deliverables to meet timelines and quality standards.
Support preparation of clinical study reports, regulatory submissions, publications and DSURs.