Principal Biostatistician - Team Build (Remote)
A well-established, secure and commercially active biopharma is expanding its US biostatistics team. This is a hands-on study statistician role within a fully in-house function.
Responsibilities
- Serve as study statistician across oncology trials
- Author and review Statistical Analysis Plans (SAPs) and statistical sections of clinical protocols
- Develop and review TFLs and outputs for regulatory submissions
- Conduct ad hoc statistical analysis and contribute to data review
- Support regulatory interactions, including IND, NDA/BLA submissions
- Collaborate cross-functionally with clinical development, data management, and programming
Experience Required
- PhD in Biostatistics or Statistics; Masters with supplementary experience considered
- Strong oncology experience
- Demonstrable experience working directly for a sponsor company
- Proficiency in SAS and/or R
- East Coast based only
Compensation
DOE - $160,000 - $200,000 base salary + benefits Remote Skills: Biostatistics, Clinical Data Management, Clinical Practices/Protocols, Cross-Functional, Drug Development, Oncology, R Programming Language, Regulations, Regulatory Submissions, Statistics, Writing Skills About the Company: Astera Search