Remote Principal Statistical Programmer - Lead

Placements24

Klerksdorp

Remote

ZAR 1,488,000 - 2,479,000

Full time

9 days ago

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Job summary

Placements24 is recruiting a Senior/Principal Statistical Programmer SAS + R for a fully remote role with a sponsor-dedicated pharmaceutical client. The role focuses on SDTM/ADaM development, regulatory submissions, and CRO oversight in a fast-paced biotech environment.

The candidate should have 7+ years in statistical programming, strong SAS skills, CDISC proficiency, and excellent communication and leadership abilities. Remote work option with global collaboration and regulatory exposure.

Qualifications

  • 7+ years of experience as a Statistical Programmer on Biotech/Pharma teams.
  • Bachelor's degree in CS, data science, math or statistics.
  • Extensive CDISC (SDTM, ADaM, Define.xml) and FDA/ICH knowledge.
  • Experience supporting regulatory submissions and interacting with FDA.
  • Strong independence and leadership capabilities.

Responsibilities

  • Generate SDTM, ADaM specs, datasets, define.xml and reviewers' guides.
  • Develop SAS programs for datasets, listings, tables and graphs.
  • Oversee CROs' programming deliverables to meet timelines.
  • Support clinical study reports, regulatory submissions, DSUR, and analyses.
  • Collaborate with CROs, vendors and partners to meet goals.
  • Create and maintain programming standards and SOPs.

Skills

SAS programming
Leadership
Communication skills
Independent worker

Education

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

R
Python
Java
Shiny
Unix/Linux
git

Job description

Placements24 is recruiting a Senior/Principal Statistical Programmer SAS + R for a fully remote role with a sponsor-dedicated pharmaceutical client. The role focuses on SDTM/ADaM development, regulatory submissions, and CRO oversight in a fast-paced biotech environment.

The candidate should have 7+ years in statistical programming, strong SAS skills, CDISC proficiency, and excellent communication and leadership abilities. Remote work option with global collaboration and regulatory exposure.

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