Location: Flexible (Hybrid or Remote options available)
About the Role
We are seeking a Director of Biostatistics to provide strategic and hands-on leadership across clinical development programs. This role partners closely with Clinical Development, Regulatory, Statistical Programming, Data Management, and other cross-functional teams to ensure high-quality statistical strategy, execution, and regulatory delivery.
Key Responsibilities
- Lead statistical strategy across one or more clinical development programs (Phase I–III and/or post-marketing).
- Serve as the primary statistical point of contact for cross-functional stakeholders, including Clinical, Regulatory, Medical Affairs, and RWE/HEOR as applicable.
- Oversee study design, analysis plans, and interpretation of results to support program-level decision making.
- Review and guide key regulatory deliverables, including protocols, SAPs, CSRs, and submissions.
- Manage, mentor, and develop biostatistics team members and/or matrixed statisticians.
- Provide technical leadership on complex statistical methodologies and ensure alignment with regulatory expectations.
- Contribute to departmental process improvements, standards, and long-term biometrics strategy.
Qualifications
- PhD or MS in Biostatistics, Statistics, or a related field.
- 6+ years of industry experience in biostatistics within pharma or biotech.
- Demonstrated leadership experience, including mentoring and influencing teams.
- Strong understanding of clinical trial design, regulatory requirements, and drug development.
- Ability to communicate complex statistical concepts clearly to non-statistical audiences.
- Experience interacting with regulatory agencies preferred.
Why This Role
- Opportunity to influence development strategy at the program and portfolio level.
- High visibility across senior scientific and clinical leadership.
- Collaborative environment with strong cross-functional partnership.
- Competitive compensation, equity participation, and long-term growth potential.