Senior Principal Statistical Programmer - Remote (SAS/R)

Samancor Chrome Ltd.; South Africa; Remote; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Equal Employment Opportunity

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead statistical programming for clinical development programs. The role involves working with a sponsor, implementing reporting tasks, and ensuring data quality across SDTM/ADaM specifications, datasets, and define.xml files.

The candidate should have 7+ years of experience in biotech/pharma programming, strong SAS skills, CDISC expertise, and the ability to work independently with global teams.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 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 statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and deliver high-quality results.
• Strong written and verbal communication skills and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and Define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs for development programs.
• Oversee CRO programming deliverables for multiple studies to ensure quality and timelines.
• Assist in preparation of CSR, regulatory submissions, publications, and DSUR analyses.
• Collaborate with internal/external partners to meet project goals and timelines.

Skills

SAS

R

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 (Remote) to lead statistical programming for clinical development programs. The role involves working with a sponsor, implementing reporting tasks, and ensuring data quality across SDTM/ADaM specifications, datasets, and define.xml files.

The candidate should have 7+ years of experience in biotech/pharma programming, strong SAS skills, CDISC expertise, and the ability to work independently with global teams.