What are the responsibilities and job description for the Senior Director of Biostatistics and Clinical Development position at EyePoint Pharmaceuticals?
About EyePoint Pharmaceuticals
We are a leading ophthalmology company dedicated to preventing blindness through innovative therapeutics. Our vision is to transform the lives of patients by developing and commercializing groundbreaking treatments.
Job Summary
The Senior Director, Biostatistics will provide technical leadership and statistical expertise in the design and execution of late-stage ophthalmology clinical trials. This role will contribute to protocol development, ensuring trial design, sample size, and statistical methodologies are appropriate and efficient.
Key Responsibilities:
- Provide technical leadership and statistical expertise in the design and execution of late-stage ophthalmology clinical trials.
- Contribute to protocol development, ensuring trial design, sample size, and statistical methodologies are appropriate and efficient.
- Lead the development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses.
- Review clinical data for accuracy, perform statistical analyses, interpret study results, and collaborate with cross-functional teams to produce interim and final reports, as well as publications.
Requirements:
- Extensive biopharmaceutical industry experience required.
- Deep understanding of clinical trial processes (NDAs/MAAs) and statistical programming requirements for regulatory submissions.
- Experience providing statistical support for Medical Affairs and Market Access activities.
- Technical expertise in statistical methodology and strong programming skills with SAS or R.
