Principal Statistical Programmer – Remote (SAS & R)

Vencorp Placements; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely within one of our pharmaceutical clients. You will work independently with limited supervision, oversee CRO programmers, and deliver data summaries for sponsor trials across multiple therapeutic areas.

Responsibilities include generating SDTM/ADaM specifications and datasets, writing SAS and R programs for tables and graphs, contributing to study reports and regulatory submissions, and ensuring compliance with

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in biotech/pharma clinical development biometrics.
• Exceptional SAS programming skills and expertise in clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs which generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs.
• Oversee CROs' programming deliverables to meet timelines and quality expectations.
• Support preparation of clinical study reports, regulatory submissions, publications and DSUR.
• 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.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines and goals.
• Review or author SOPs and Work Instructions related to statistical programming.

Skills

SAS programming

R programming

CDISC SDTM/ADaM/Define.xml

Clinical development experience

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely within one of our pharmaceutical clients. You will work independently with limited supervision, oversee CRO programmers, and deliver data summaries for sponsor trials across multiple therapeutic areas.

Responsibilities include generating SDTM/ADaM specifications and datasets, writing SAS and R programs for tables and graphs, contributing to study reports and regulatory submissions, and ensuring compliance with