Director Biostatistics
EPM Scientific, New York, NY, United States
Project Overview
- Project Type: Solid Tumours, Oncology
- Location: Anywhere in United States, Fully Remote
- Contract Type: Contract, 9 Months
- Start Date: As soon as possible
Key Responsibilities
- Lead statistical aspects of clinical trials, ensuring high‑quality analyses, documentation, and regulatory‑ready deliverables.
- Partner cross‑functionally with Clinical, Regulatory, Programming, Data Management, and Safety teams to support development strategy.
- Contribute to regulatory submissions and interactions, including statistical sections of INDs, NDAs/BLAs, and briefing materials.
- Oversee and mentor statisticians, ensuring strong technical execution and resource alignment across projects.
- Drive use of modern statistical methods and best practices to enhance scientific and operational quality.
- Support publications, presentations, and external communication of study results.
Requirements
- Strong experience (8+ years preferred) in Biostatistics strongly preferred.
- Experience with Submissions is essential.
- Experience with Solid Tumors is strongly preferred.
- Advanced degree in life sciences, medicine, or pharmacy preferred.
- Ability to work independently, with excellent communication and stakeholder engagement skills.
If this position sounds interesting, please apply directly.
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