Director of Biostatistics

Location: Boston, MA Preferred | Remote Considered

Our client, a well-funded clinical-stage biotechnology company, is seeking a Director, Biostatistics to provide strategic and operational statistical leadership across multiple clinical development programs. Reporting to the Head of Biometrics, this individual will serve as the lead statistical expert, partnering closely with cross-functional teams to guide study design, data analysis, regulatory submissions, and overall development strategy.

This is a highly visible, hands-on role offering the opportunity to influence development decisions and build statistical capabilities within a growing organization.

Key Responsibilities

• Serve as the statistical lead across one or more clinical development programs.
• Provide input into protocol design, statistical methodologies, analysis plans, and study execution.
• Author and review key statistical documents, including SAPs and regulatory submission deliverables.
• Lead statistical analyses and interpretation of clinical trial data.
• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Safety, and Medical Writing teams.
• Support regulatory interactions and submission activities.
• Oversee CROs and external statistical programming vendors.
• Ensure compliance with industry standards, regulatory guidance, and data quality requirements.
• Contribute to statistical standards, processes, and best practices across the organization.
• Mentor team members and provide technical leadership within Biometrics.

Qualifications

• PhD or Master's degree in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years of biotechnology and/or pharmaceutical industry experience in clinical biostatistics.
• Demonstrated experience leading statistical strategy from study design through regulatory submission.
• Strong knowledge of FDA, EMA, ICH, and CDISC requirements.
• Experience supporting regulatory submissions and health authority interactions.
• Proven ability to manage external vendors and CRO partnerships.
• Proficiency with SAS; experience with R preferred.
• Prior experience within a clinical-stage biotech environment is strongly preferred.

Preferred Background

• Experience supporting rare disease, immunology, or other specialized therapeutic areas.
• Familiarity with innovative clinical trial designs, small patient populations, or complex development programs.
• Ability to balance strategic leadership with hands-on execution.