Senior Principal Statistical Programmer (SAS + R) – Remote

Placements24

East London

Remote

ZAR 1,487,000 - 2,479,000

Full time

4 days ago
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Job summary

Placements24 is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role with Cytel's sponsor-dedicated program. You will lead programming activities for clinical development programs, oversee CROs, and deliver high-quality SDTM/ADaM outputs and regulatory deliverables.

You will work independently with minimal supervision, requiring strong SAS expertise, CDISC standards knowledge, and experience with FDA/ICH regulations.

Qualifications

  • Bachelor’s degree in a relevant field is preferred; 7+ years of experience as a Statistical Programmer in Biotech/Pharma.
  • Exceptional SAS programming skills and CDISC standards expertise (SDTM/ADaM/Define.xml).
  • Experience supporting regulatory submissions and interacting with FDA/ICH.
  • Ability to work independently with strong communication and leadership.

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.
  • Deliver high-quality SAS and/or R programs for clinical development programs.
  • Oversee CROs’ statistical programming deliverables to meet timelines.
  • Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
  • Follow FDA regulations and GCP for electronic submissions.
  • Contribute to standards for programming tools, outputs, and macros.
  • Develop CRFs, edit check specs, and data validation plans.

Skills

SAS programming
CDISC SDTM/ADaM
Regulatory submissions
Leadership
Communication skills
Clinical trial methods

Education

Bachelor's degree in Computer Science/Statistics/Math/Data Science

Tools

R
Python
Unix/Linux
Git

Job description

Placements24 is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role with Cytel's sponsor-dedicated program. You will lead programming activities for clinical development programs, oversee CROs, and deliver high-quality SDTM/ADaM outputs and regulatory deliverables.

You will work independently with minimal supervision, requiring strong SAS expertise, CDISC standards knowledge, and experience with FDA/ICH regulations.

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