Director of Biostatistics
Fully Remote – USA
The Director of Biostatistics will provide statistical leadership across clinical development programs, supporting study design, analysis, and interpretation of data from early through late-stage trials.
This role will work closely with cross-functional teams to ensure robust statistical methodology, high-quality deliverables, and alignment with overall development and regulatory strategies. The Director will also play a key role in managing vendors and contributing to the broader biometrics function.
Key Responsibilities
- Lead statistical strategy and provide input into clinical development plans and study design
- Author and review key statistical documents, including statistical analysis plans (SAPs) and study reports
- Oversee statistical outputs such as tables, listings, and figures (TLFs)
- Collaborate with Clinical Development, Data Management, and Regulatory teams to ensure alignment across programs
- Provide statistical input into protocols, including endpoint selection, sample size calculations, and analysis methods
- Support regulatory submissions and interactions with health authorities
- Manage external vendors and CROs to ensure quality, timelines, and compliance
- Review and interpret study data, contributing to internal decision-making and external presentations
- Support publications, abstracts, and presentations of clinical data
- Mentor junior statisticians and contribute to team development where applicable
Qualifications
- MD or PhD in Statistics, Biostatistics, or a related field
- 8–12+ years of experience within biotech, pharmaceutical, or CRO environments
- Strong experience in clinical trial design, statistical analysis, and reporting
- Experience supporting regulatory submissions and health authority interactions
- Prior experience working with CROs and external vendors
- Ability to work both independently and collaboratively within cross-functional teams