Senior Biostatistician - Lead SAS Analytics & Clinical Stats

TOTAL TRIALS INC; Centurion; On-site; ZAR 1,000,000 - 1,500,000; Full time

Job summary

FHI Clinical in South Africa seeks a Senior Biostatistician to lead statistical activities on clinical projects in compliance with ICH GCP and global guidelines. You will write SAPs, create analysis datasets, and oversee TFL development and reporting.

The role requires expert SAS programming, data validation, and collaboration with study teams, vendors, and clients, including manuscript support and DSMB liaison.

Qualifications

• Master's degree in statistics, biostatistics, bioinformatics, mathematics, public health or related field.
• 5-8 years of relevant work experience in statistical analysis of research studies.
• Strong leadership, mentoring, and collaboration skills.
• Excellent written and verbal communication in English.

Responsibilities

• Write statistical analysis plans (SAPs) and statistical programs to generate tables, listings and figures.
• Perform statistical analyses and validate analysis data sets and TFLs.
• Develop and maintain analysis data sets and TFL specifications.
• Draft statistical sections of study reports and contribute to manuscripts.
• Provide statistical input to study teams on randomization and analysis conduct.
• Support DSMB meetings and communicate timelines and data quality issues.
• Guide and oversee direct report(s) including workload and career development.
• Ensure compliance with ICH GCP, FDA/EMA guidelines and procedural documents.
• Refine protocols and manuscripts; maintain program documentation.

Job description

FHI Clinical in South Africa seeks a Senior Biostatistician to lead statistical activities on clinical projects in compliance with ICH GCP and global guidelines. You will write SAPs, create analysis datasets, and oversee TFL development and reporting.

The role requires expert SAS programming, data validation, and collaboration with study teams, vendors, and clients, including manuscript support and DSMB liaison.