Senior Biostatistician - Clinical Trials

Placements24; Stellenbosch; Hybrid; ZAR 1,100,000 - 1,800,000; Full time

Benefits offered by this job

Salary + bonus

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Placements24 is seeking a Senior Biostatistician for its Clinical Trials division in Stellenbosch. You will design, analyze, and report statistical aspects of clinical studies, ensuring regulatory compliance and scientific rigor.

You will collaborate with researchers, data managers, and regulatory affairs to interpret complex data and contribute to pivotal trials in life‑saving therapeutics, requiring strong statistical expertise and knowledge of ICH/FDA/EMA guidelines.

Qualifications

• Master’s or Ph.D. in Statistics, Biostatistics, or related quantitative field.
• Minimum of 5 years of biostatistics experience in pharma/biotech, with clinical trials.
• Proficiency in SAS and R.
• Strong understanding of clinical trial design, data analysis, and regulatory requirements.
• Excellent analytical and problem‑solving skills, with meticulous attention to detail.
• Effective communication and collaboration with cross-functional teams in Stellenbosch.

Responsibilities

• Design statistical analysis plans for clinical studies, including sample size calculations and randomization schemes.
• Perform complex statistical analyses on clinical trial data using SAS, R, or similar statistical software.
• Interpret statistical results and provide insights to clinical teams for study reports and publications.
• Ensure statistical methods and analyses adhere to regulatory guidelines (ICH, FDA, EMA).
• Collaborate with data management teams to ensure data quality and integrity for statistical analysis.
• Contribute to the development of study protocols and IND applications in Stellenbosch.

Skills

Analytical thinking

Cross-functional collaboration

Education

Master’s or Ph.D. in Statistics/Biostatistics

5+ years in biostatistics

Tools

SAS

R

Job description

About the Role

Our client is looking for a highly skilled Senior Biostatistician to play a critical role in their Clinical Trials division in Stellenbosch. This position involves the design, analysis, and reporting of statistical aspects for clinical studies, ensuring scientific rigor and regulatory compliance. You will work closely with clinical researchers, data managers, and regulatory affairs specialists to interpret complex data and contribute to the development of life‑saving therapeutics. The ideal candidate possesses a strong statistical background and a deep understanding of clinical research methodologies, contributing to the success of pivotal trials.

Key Responsibilities

• Design statistical analysis plans for clinical studies, including sample size calculations and randomization schemes.
• Perform complex statistical analyses on clinical trial data using SAS, R, or similar statistical software.
• Interpret statistical results and provide insights to clinical teams for study reports and publications.
• Ensure statistical methods and analyses adhere to regulatory guidelines (e.g., ICH, FDA, EMA).
• Collaborate with data management teams to ensure data quality and integrity for statistical analysis.
• Contribute to the development of study protocols and investigational new drug (IND) applications in Stellenbosch.

Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 5 years of experience in biostatistics within the pharmaceutical or biotechnology industry, specifically with clinical trials.
• Proficiency in statistical programming languages such as SAS and R.
• Strong understanding of clinical trial design, data analysis, and regulatory requirements.
• Excellent analytical and problem‑solving skills, with meticulous attention to detail.
• Effective communication and collaboration skills to work with cross-functional teams in Stellenbosch.

Benefits

• Competitive annual salary and bonus structure.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer match.
• Generous paid time off and opportunities for professional development.
• Exposure to cutting-edge research and development in drug discovery.
• A collaborative and scientifically driven work environment.