Biostatistician; Clinical Trials

About the Role

Our client is seeking a skilled Biostatistician with expertise in clinical trials to join their growing team in Stellenbosch . This hybrid role allows for a balance of remote work and collaborative sessions at our modern facility. You will be responsible for designing statistical analysis plans, performing complex statistical analyses, and interpreting results for various clinical studies. Your insights will be crucial in informing critical decisions about drug development and efficacy.

The ideal candidate possesses strong analytical skills, proficiency in statistical software, and a solid understanding of clinical trial methodologies and regulatory requirements. This role offers the chance to contribute to life-saving research in a stimulating environment.

• Develop statistical analysis plans (SAPs) for clinical trials in collaboration with clinical teams and regulatory experts.
• Perform statistical analyses using SAS, R, or other relevant software packages according to SAPs.
• Generate tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions.
• Contribute to study design, sample size calculations, and randomization schemes.
• Review and provide statistical input on clinical protocols, case report forms (CRFs), and other study documents.
• Stay abreast of statistical methodologies, regulatory guidelines, and industry best practices.

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 3 years of experience in biostatistics, specifically within the pharmaceutical or biotechnology industry, focusing on clinical trials.
• Proficiency in statistical programming languages such as SAS and/or R.
• Solid understanding of clinical trial design, data management, and regulatory requirements (e.g., ICH, FDA, EMA).
• Excellent analytical, problem-solving, and written/verbal communication skills.
• Ability to work effectively both independently and as part of a multidisciplinary team.

• Competitive annual salary and potential for performance bonuses.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plan with employer contributions.
• Support for ongoing professional development, including conference attendance and training.
• Flexible hybrid work arrangement to promote work-life balance.