Senior Biostatistician

Role Summary

The Senior Biostatistician provides, and may lead, statistical contributions to a clinical development program. The Principal Biostatistician implements statistical strategies for clinical trials and regulatory submissions within the program and is accountable for all statistical deliverables.

Main Responsibilities and Accountabilities

• Contribute to the statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Provide statistical support for data collection, analysis, reporting, and submission preparation.
• Ensure the timely completion and quality of the Statistical Analysis Plan (SAP).
• Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
• Interpret analysis results and ensure accuracy and clarity of reporting.
• Manage outsourced statistical activiti...