Principal Biostatistician - Home Based (SA) (Clinical Research)

Location: Home based in South Africa, with listed locations including Bloemfontein, Johannesburg, Pretoria, Cape Town, and Durban.

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data analysis and regulatory submissions.

What you will do

• Lead complex biostatistical projects, programs, and regulatory submissions while managing client meetings and collaborating with regulatory teams, project managers, sponsors, and programmers.
• Develop and review statistical analysis plans, including SAPs, iSAPs, text, and shells, independently.
• Review or develop ADaM specifications and resolve comments with programmers and junior statisticians.
• Prepare statistical methods and results sections for clinical study reports and contribute to sponsor protocols and study-design decisions.
• Perform sample size calculations, create randomization and kit schedules, and provide statistical consulting to sponsors.
• Support Data Safety Monitoring Boards as an unblinded statistician, present findings, and contribute to industry publications and white papers.

Requirements

• Master’s degree in Biostatistics, Statistics, or a related field; a PhD is preferred.
• At least 7 years of experience in biostatistics, statistics, or a similar field.
• Experience with clinical trial submissions, including ISS and ISE.
• Advanced knowledge of drug development, scientific principles, clinical data, and CRO processes.
• Familiarity with 21 CFR Part 11, FDA, GCP, and current regulatory guidelines.
• Strong communication, organization, problem-solving, collaboration, and MS Office skills.

Nice to have

• Hands-on experience with clinical trial and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.
• PhD in Biostatistics, Statistics, or a related discipline.

Culture & Benefits

• Home-based full-time work arrangement in South Africa.
• Collaborative and inclusive environment with opportunities to guide other statisticians.
• Work within an award-winning CRO with a global footprint across four continents.
• Opportunities to contribute to external presentations, blogs, and white papers.