Biostatistics Strategy Leader - Executive Director (Remote)

BioCryst Pharmaceuticals, Inc.; Durham, Northern (NC, KY); Hybrid; USD 200,000 - 260,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks an Executive Director of Biostatistics to lead design, analysis and interpretation of Phase I–IV studies and related non-clinical work. The role emphasizes regulatory strategy and outsourcing management across Biostatistics & Data Science.

You will oversee CROs, ensure GCP compliance, author SAPs and regulatory responses, and translate complex statistics for diverse technical and nontechnical stakeholders worldwide. Travel is expected.

Qualifications

• Ph.D. in Biostatistics with 12+ years in pharma biostatistics and programming.
• Strong regulatory and NDA/MAA experience with clinical development.
• Proven leadership, project management, and vendor oversight.

Responsibilities

• Lead Biostatistics support for BioCryst-sponsored studies (Phase I–IV).
• Oversee CRO/contract staff and outsourcing activities with budgets.
• Ensure GPCP/GCP-aligned statistical methods and regulatory compliance.
• Author/reviewer SAPs, protocols, and regulatory documentation.
• Communicate complex statistics clearly to technical and regulatory audiences.

Skills

Biostatistics leadership

SAS programming

Regulatory knowledge

Communication skills

Team leadership

Education

Ph.D. in Biostatistics (or related field)

Tools

SAS

Job description

BioCryst Pharmaceuticals, Inc. seeks an Executive Director of Biostatistics to lead design, analysis and interpretation of Phase I–IV studies and related non-clinical work. The role emphasizes regulatory strategy and outsourcing management across Biostatistics & Data Science.

You will oversee CROs, ensure GCP compliance, author SAPs and regulatory responses, and translate complex statistics for diverse technical and nontechnical stakeholders worldwide. Travel is expected.