3h ago
Director, Biostatistics - Early Phase
Redwood City, California, United States
full-timedirector Hybridbiotechnology
Tech Stack
Description
You will provide statistical leadership and support for clinical development strategy and studies, collaborating with cross-functional teams on study design and regulatory submissions. Your work will directly impact the development of novel targeted therapies for patients with RAS-addicted cancers.
Requirements
- PhD in Statistics/Biostatistics with 8+ years industry experience, or MS with 12+ years
- Hands-on experience in design and analysis of oncology trials
- Solid knowledge of ICH and regulatory requirements
- Excellent verbal and written communication skills
- Proficiency in SAS and/or R
Responsibilities
- Provide statistical leadership for clinical program(s) and studies
- Support clinical development plans, target product profiles, and proof of concept criteria
- Collaborate with data management, clinical operations, and statistical programming
- Prepare for regulatory interactions and health authority submissions
- Lead department initiatives and best practices
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