Senior Quantitative Analyst - Clinical Trials

Job Description

We are seeking a Biostatistics Expert to lead statistical strategies and deliverables for our R&D sponsored clinical trials. This includes contributing to the planning, execution, and interpretation of statistical analyses across development programs to ensure high-quality, timely deliverables that meet regulatory and scientific standards.

• Lead biostatistics efforts for assigned studies and projects.
• Collaborate with cross-functional teams on study design discussions, including protocol development, endpoint definition, and sample size estimation.
• Develop and review Statistical Analysis Plans (SAPs).
• Oversee statistical programming activities and manage deliverables from vendors and CRO partners.
• Communicate project status to stakeholders and escalate issues or risks in a timely manner.
• Provide statistical input and review for clinical study reports, regulatory documents, and publications.
• Evaluate the quality of statistical outputs to ensure accuracy and compliance with internal standards.
• Interact with regulatory authorities on statistical issues and applicable statistical strategies for handling clinical and regulatory considerations.
• Present statistical findings to internal and external stakeholders as needed.