Key Responsibilities

• Collaborate w/clinical teams to develop study design & protocol, incl 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, & 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, & regulatory guidelines.
• Conduct quality checks & audits of statistical analysis processes and outputs to uphold data quality and reliability.