Senior Biostatistician

Placements24; Stellenbosch; Hybrid; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation

Job summary

Placements24 in Stellenbosch, South Africa, seeks a Senior Biostatistician to provide statistical expertise across clinical trials, from design to reporting. The role balances on-site collaboration at our Stellenbosch facility with remote data analysis.

The ideal candidate has a Master's or PhD in Statistics/Biostatistics, 5+ years of biostatistics experience in pharma or biotech, and strong SAS and R proficiency. You will mentor juniors and interact with regulatory bodies.

Qualifications

• Master's or PhD in Statistics/Biostatistics or related field.
• At least 5 years of biostatistics experience in pharma/biotech.
• Proficiency in SAS and R.
• Strong understanding of clinical trial design and statistics.
• Knowledge of ICH guidelines and regulatory requirements.
• Excellent analytical and communication abilities.
• Ability to work independently in a hybrid environment.
• Experience collaborating with regulators and investigators.

Responsibilities

• Provide statistical input for trial design, including sample size calculations.
• Develop SAPs for clinical studies.
• Analyze trial data using SAS, R, or other software.
• Interpret results and contribute to CSRs, publications and presentations.
• Collaborate with operations, data management, and medical writing teams.
• Ensure adherence to statistical principles and SOPs.
• Review CRFs and database design for statistical integrity.
• Mentor junior biostatisticians and contribute to standards.
• Engage in regulatory interactions and respond to queries.

Skills

Analytical thinking

Communication skills

Education

Master's or PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

About the Role

Our client, a leading pharmaceutical research organization based in Stellenbosch, Western Cape, ZA, is looking for a highly analytical and experienced Senior Biostatistician. This hybrid role will involve providing statistical expertise for clinical trials, from study design and protocol development through to data analysis and reporting. You will play a crucial role in interpreting complex clinical data and ensuring the integrity and validity of research findings. The ideal candidate will have a strong foundation in statistical methodologies applied to clinical research and excellent communication skills to collaborate effectively with investigators, data managers, and regulatory bodies. This position requires a balance of on-site collaboration and remote analytical work.

Key Responsibilities

• Provide statistical input for the design of clinical trials, including sample size calculations and randomization schemes.
• Develop statistical analysis plans (SAPs) for clinical studies.
• Perform statistical analyses of clinical trial data using SAS, R, or other relevant software.
• Interpret statistical results and contribute to clinical study reports (CSRs), publications, and presentations.
• Collaborate with clinical operations, data management, and medical writing teams.
• Ensure adherence to statistical principles, regulatory guidelines (e.g., ICH), and company SOPs.
• Review Case Report Forms (CRFs) and database design for statistical integrity.
• Stay up-to-date with the latest advancements in statistical methodologies and their application in clinical research.
• Mentor junior biostatisticians and contribute to the development of statistical standards and tools.
• Participate in regulatory agency interactions and contribute to responses to regulatory queries.

Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 5 years of experience in biostatistics, preferably within the pharmaceutical or biotech industry.
• Proficiency in statistical software packages such as SAS (mandatory) and R.
• Strong understanding of clinical trial design and statistical methodologies relevant to pharmaceutical development.
• Knowledge of ICH guidelines and regulatory requirements for statistical reporting.
• 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 manage multiple projects concurrently.
• Experience working in a hybrid environment, including on-site presence in Stellenbosch, Western Cape, ZA and remote analysis.

Benefits

Our client offers a competitive salary and a comprehensive benefits package. This hybrid role provides flexibility, allowing for remote data analysis while maintaining essential on-site collaboration and team interaction at our Stellenbosch facility. Opportunities for professional growth and development within a scientifically driven organization. Contribute to life-changing clinical research and drug development. Be part of a dedicated team of experts committed to advancing healthcare. This is an excellent opportunity for a skilled Biostatistician to enhance their career.