About the Role
Our client, a leading contract research organization (CRO) supporting global pharmaceutical and biotech companies, is seeking a talented Senior Biostatistician to join their growing team in Kimberley, Northern Cape, ZA. This role is pivotal in the design, analysis, and reporting of clinical trials, ensuring the statistical integrity of the data generated. You will be responsible for developing statistical analysis plans, performing complex statistical analyses, and interpreting results to support regulatory submissions and research objectives. The ideal candidate will possess a strong quantitative background, extensive experience in biostatistics within clinical research, and a thorough understanding of statistical software. This position offers a challenging and rewarding career opportunity within a dynamic team, operating under a hybrid work model that allows for both effective collaboration and focused individual contribution. We are committed to advancing medical science through rigorous statistical methodology.
Key Responsibilities
- Develop Statistical Analysis Plans (SAPs) for clinical trials in collaboration with clinical teams and regulatory experts.
- Design clinical trial datasets and specify analysis requirements.
- Perform statistical analyses of clinical trial data using statistical software packages (e.g., SAS, R).
- Interpret statistical results and provide insights to support decision-making.
- Prepare statistical sections of clinical study reports, regulatory submissions, and publications.
- Ensure adherence to statistical principles, regulatory guidelines (e.g., ICH), and company SOPs.
- Participate in study design and protocol development meetings.
- Review and validate statistical programs and outputs.
- Mentor junior biostatisticians and contribute to the development of statistical methodologies.
Requirements
- Master's or PhD degree in Statistics, Biostatistics, or a related quantitative field.
- Minimum of 5-7 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, or a CRO.
- Proficiency in statistical analysis software such as SAS (required) and R (preferred).
- Strong understanding of clinical trial design, data management, and regulatory requirements (e.g., ICH E9).
- Experience in analyzing data from various phases of clinical trials.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to explain complex statistical concepts clearly.
- Ability to work independently and collaboratively in a team environment.
- Experience with adaptive trial designs and survival analysis is a plus.
Benefits
- Competitive salary commensurate with experience and qualifications.
- Hybrid work environment promoting work-life balance.
- Comprehensive medical and retirement benefits package.
- Opportunities for professional growth, training, and attending conferences.
- Exposure to a diverse range of clinical trials and therapeutic areas.
- A collaborative and supportive team culture.
- Generous annual leave allowance.
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Senior Biostatistician - Clinical Trials in Kimberley employer: Placements24
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