Barrington James - Philadelphia, PA
posted 12 days ago
Full-time - Principal
Philadelphia, PA
Administrative and Support Services
About the position
The Principal Biostatistician will serve as the subject matter expert (SME) in biostatistics, focusing on late-phase studies and collaborating closely with regulatory teams for submissions to the FDA. This role is critical in supporting the company's advancements in cell and gene therapies, contributing to the overall success and reputation of the organization in the biotech industry.
Responsibilities
- Serve as the Biostatistics subject matter expert (SME) for late-phase studies.
- Collaborate with regulatory teams on submissions to the FDA.
- Provide statistical expertise and guidance throughout the study lifecycle.
- Develop and validate statistical analysis plans and methodologies.
- Interpret and communicate statistical results to stakeholders.
Requirements
- MS or PhD in a relevant field.
- 6+ years of experience in biostatistics.
- Prior experience with FDA or regulatory submissions is beneficial.
