Principal Statistical Programmer (SAS + R) — Remote

Mediclinic

South Africa

Remote

ZAR 900,000 - 1,500,000

Full time

5 days ago
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Job summary

Cytel invites applications for a Senior/Principal Statistical Programmer (SAS + R) working remotely in South Africa. You will lead statistical programming across clinical development programs, generating SDTM/ADaM outputs, and guiding CROs to ensure timely, high-quality data delivery.

Regulatory submission experience and independence are essential. You will collaborate with biostatistics and programming teams, contribute to CRFs and data validation plans, and support regulatory interactions with

Qualifications

  • Minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
  • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
  • Exceptional SAS programming skills and expertise in clinical development environments.
  • Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
  • Experience supporting regulatory submissions and interactions with FDA/global authorities.
  • Ability to work independently with strong communication and leadership skills.

Responsibilities

  • Generate SDTM, ADaM specifications, datasets, reviewer\'s guides, and define.xml files for multiple studies.
  • Develop SAS programs to create datasets, complex listings, tables, and graphs.
  • Deliver high-quality statistical programming results including SAS and/or R programs tailored to development programs.
  • Oversee CRO programming deliverables to meet timelines and quality standards.
  • Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Skills

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

Education

Bachelor's degree in Computer Science/Statistics

Tools

SAS
R
Unix/Linux

Job description

Cytel invites applications for a Senior/Principal Statistical Programmer (SAS + R) working remotely in South Africa. You will lead statistical programming across clinical development programs, generating SDTM/ADaM outputs, and guiding CROs to ensure timely, high-quality data delivery.

Regulatory submission experience and independence are essential. You will collaborate with biostatistics and programming teams, contribute to CRFs and data validation plans, and support regulatory interactions with

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