In this role, reporting to the Vice President of Biometrics, you will work with cross-functional clinical teams overseeing statistical activities across clinical programs, including managing statistical deliverables outsourced to CROs. This is an exciting opportunity to contribute to the development of transformative therapies.
Responsibilities:
Serve as a biostatistics expert for clinical programs.
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).