Senior VP, Biostatistics & Regulatory Strategy

BioCryst Pharmaceuticals, Inc.; Durham, Boston (NC, MA); On-site; CAD 250,000 - 380,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks a Vice President of Biostatistics to lead statistical strategy, design, and analysis for pivotal clinical studies. You will manage staff, vendors, and global regulatory interactions while advancing state-of-the-art methodologies.

You will ensure quality, timeliness, and regulatory compliance across NDA/BLA activities and contribute to product development decisions with a strategic, data-driven approach.

Qualifications

• Ph.D. in Biostatistics or related field.
• Experience leading biostatistics teams in pharma/biotech.
• Strong communication with regulatory bodies.

Responsibilities

• Oversee statistical activities for BioCryst-sponsored studies.
• Lead regulatory submissions including NDA/BLAs.
• Ensure GCP conformance in statistical work.

Skills

Leadership

Communication

Regulatory experience

Statistical design

Adaptive trial design

Bayesian statistics

Education

Ph.D. in Biostatistics

Tools

SAS

EAST

R

Job description

BioCryst Pharmaceuticals, Inc. seeks a Vice President of Biostatistics to lead statistical strategy, design, and analysis for pivotal clinical studies. You will manage staff, vendors, and global regulatory interactions while advancing state-of-the-art methodologies.

You will ensure quality, timeliness, and regulatory compliance across NDA/BLA activities and contribute to product development decisions with a strategic, data-driven approach.