Lead Biostatistician - Pharmaceutical Development

Placements24; Cape Town; Sur place; ZAR 1 500 000 - 2 000 000; Plein temps

Avantages offerts par ce poste

Private medical insurance

Life assurance

Pension scheme

Résumé du poste

Placements24 is seeking a senior Lead Biostatistician in Cape Town to lead the statistical design and analysis of clinical trials and to direct a team of biostatisticians. You will develop SAPs, oversee regulatory submissions, and collaborate with cross-functional teams to ensure high-quality statistical outputs.

The ideal candidate will have a Ph.D. or Master’s in Biostatistics, 10+ years in pharma, expertise in SAS and R, and a strong grasp of ICH/FDA/EMA guidelines.

Qualifications

• Ph.D. or Master’s in Biostatistics or related quantitative field from an accredited institution.
• Minimum of 10 years of experience in biostatistics within pharma/biotech.
• Proven leadership in statistical aspects of clinical trials from design to reporting.
• Expertise in SAS and R; proficient with statistical modeling.
• Strong understanding of regulatory guidelines (ICH, FDA, EMA).
• Excellent communication and leadership abilities.

Responsabilités

• Lead the design and analysis of clinical trials with regulatory rigor.
• Develop and implement SAPs for complex data sets.
• Mentor and manage a team of biostatisticians.
• Collaborate with clinical development, data management, and regulatory teams.
• Prepare and review CSRs, regulatory submissions, and publications.

Connaissances

SAS

R

Leadership

Communication

Project management

Formation

Ph.D. or Master’s in Biostatistics

Outils

Statistical software

Description du poste

About the Role Our client, a prominent player in the pharmaceutical landscape, is actively seeking a highly experienced and visionary Lead Biostatistician to spearhead their statistical analysis efforts in Cape Town, Western Cape. This senior position is critical for providing statistical expertise and strategic direction for clinical trial design, data analysis, and regulatory submissions. You will lead a team of talented biostatisticians, ensuring the integrity and accuracy of statistical methodologies applied across a range of cutting-edge pharmaceutical projects. This role demands a deep understanding of statistical principles in drug development and a proven ability to translate complex data into actionable insights that drive crucial decision-making processes. The ideal candidate will thrive in a collaborative environment, contributing to the advancement of novel therapeutics.

Key Responsibilities

• Lead the statistical design and analysis of clinical trials, ensuring compliance with regulatory standards and scientific rigor.
• Develop and implement statistical analysis plans (SAPs) for complex clinical data sets.
• Manage and mentor a team of biostatisticians, providing technical guidance and fostering professional growth.
• Collaborate with clinical development, data management, and regulatory affairs teams to ensure seamless project execution.
• Contribute to the preparation and review of statistical sections of clinical study reports (CSRs), regulatory submissions (e.g., IND, NDA), and publications.
• Evaluate and implement innovative statistical methodologies and software to enhance analytical capabilities.
• Serve as a key statistical expert and advisor for internal project teams and external stakeholders.
• Ensure the quality and integrity of statistical outputs and documentation.

Requirements

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related quantitative field from an accredited institution.
• A minimum of 10 years of relevant experience in biostatistics, with a significant portion within the pharmaceutical or biotechnology industry.
• Proven experience in leading statistical aspects of clinical trials from design through to reporting.
• Expertise in statistical programming languages such as SAS and R, and proficiency with statistical modeling techniques.
• Strong understanding of regulatory guidelines (e.g., ICH, FDA, EMA) relevant to statistical analysis in drug development.
• Excellent communication, presentation, and interpersonal skills, with the ability to articulate complex statistical concepts clearly.
• Demonstrated leadership and team management capabilities.
• Experience with complex study designs, adaptive trials, and real-world evidence analysis is a plus.

Benefits

• This role offers a highly competitive salary commensurate with experience, alongside a comprehensive benefits package including private medical insurance, life assurance, and a generous pension scheme.
• Our client invests in its employees' growth through continuous learning opportunities, conference attendance, and advanced training programs.
• The position is based in the vibrant city of Cape Town, providing a great work-life balance and the chance to contribute to life-changing pharmaceutical innovations.