Director of Biostatistics

Director of Biostatistics

Position Summary

We are seeking an experienced Director of Biostatistics to provide strategic and operational statistical leadership across clinical development programs. This individual will collaborate closely with Clinical Development, Data Management, Statistical Programming, Regulatory, and Medical Affairs teams to support study design, data analysis, regulatory activities, and key development decisions.

The ideal candidate is a hands-on leader with a strong background in oncology clinical trials and experience guiding programs from early development through late-stage studies.

Responsibilities

• Lead statistical strategy for clinical development programs and studies.
• Provide input into study protocols, statistical analysis plans, and clinical study reports.
• Partner cross-functionally to support study design, data interpretation, and decision-making.
• Oversee statistical analyses and ensure high-quality deliverables from internal teams and external vendors.
• Manage CROs and provide statistical oversight for outsourced activities.
• Support regulatory submissions, health authority interactions, and publication activities.
• Communicate study results and statistical insights to both technical and non-technical stakeholders.

Qualifications

• MS or PhD in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years of biostatistics experience within biotech or pharmaceutical organizations.
• Strong oncology clinical development experience required.
• Experience supporting clinical trials across multiple phases of development.
• Proficiency in SAS and/or R.
• Working knowledge of regulatory requirements and industry standards.
• Experience managing CROs and collaborating within cross-functional teams.
• Excellent communication, leadership, and problem-solving skills.

Location

• Remote within the United States
• Boston-area candidates preferred

This is an opportunity to join a growing clinical-stage biotechnology company and play a key role in advancing innovative therapies through critical development milestones.