Manager, Statistics (Oncology (Late Phase development))

Role Summary

Manager, Statistics (Oncology – Late Phase development) leads statistical activities for oncology late‑phase development programs. This role collaborates with clinical teams to design studies and protocols, including statistical methodology and sample size planning, and ensures compliance with regulatory and scientific standards. The incumbent performs statistical analyses of clinical trials, interprets results in the context of clinical objectives, and prepares statistical sections of study documents and regulatory submissions. The role also acts as a statistical consultant to clinical teams and conducts quality checks to uphold data quality and reliability.

Responsibilities

• Collaborate with clinical teams to develop study design & protocol, including statistical methodology & sample size determination.
• Ensure studies are designed to meet regulatory & scientific standards.
• Perform statistical analyses of clinical trials.
• Interpret results in context of clinical objectives.
• Prepare statistical sections of study documents, including Statistical Analysis Plan (SAP), clinical study reports, and regulatory submissions.
• Provide clear & comprehensive reports that comply with regulatory requirements.
• Act as a statistical consultant to clinical teams.
• Ensure adherence to industry standards, company policies, and regulatory guidelines.
• Conduct quality checks & audits of statistical analysis processes and outputs to uphold data quality and reliability.

Qualifications

• Identifying data or analytical issues, and assisting with providing solutions.
• Developing and utilizing statistical tools for conducting meta-analysis.
• Performing statistical computations and simulations.
• Designing, analyzing, and reporting clinical or research studies in the biotech or pharmaceutical industry.
• Performing drug development and lifecycle management in the regulated environment.

Education

• PhD in Statistics, Biostatistics, or a highly related field.