Biostatistics Leadership

Aura BioSearch is seeking a skilled Biostatistics Leadership to join our team. In this role, you will oversee statistical activities across clinical programs, collaborating with cross-functional teams to ensure the success of our transformative therapies.

Main Responsibilities

• Provide strategic input for trial designs in early-phase and late-phase studies.
• Collaborate with internal and CRO team members to coordinate statistical deliverables.
• Conduct statistical modeling for efficient study designs and address statistical issues.
• Contribute to protocol development and author statistical analysis plans.
• Review eCRF designs to ensure data collection meets analysis requirements.
• Oversee QC/QA of statistical deliverables and perform ad hoc analyses as needed.
• Support IND/NDA/MAA regulatory submissions and address queries from regulatory agencies.
• Contribute to publications, including manuscripts and presentations.
• Lead standardization and process improvement efforts for the Biostatistics function.

Requirements

• PhD in Statistics or related field, or MS with relevant experience.
• 8+ years in the pharmaceutical or biotech industry.
• Experience in clinical trial design, analysis, and reporting.
• Proficient in statistical programming (SAS and R).
• Familiarity with FDA, EMA, and ICH regulations.
• Strong communication and collaborative skills.

Join our Biostatistics team to contribute to the development of innovative therapies and drive excellence in clinical research.