Executive Director, Biostatistics & Data Science

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 180,000 - 280,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking an Exec.

Director, Biostatistics to lead the design and analysis of clinical studies from Phase I to IV, oversee outsourcing, and drive advanced statistical methods in support of regulatory submissions. The role requires deep biostatistical expertise, vendor management, and the ability to communicate complex concepts clearly to regulatory and nontechnical audiences.

Qualifications

• Ph.D. in Biostatistics (or related field) with 12+ years in pharma clinical trials.
• Strong leadership and interpersonal skills; NDA filing experience preferred.
• Proven expertise in biostatistics, programming, and clinical data management.

Responsibilities

• Lead Biostatistics support for BioCryst-sponsored studies and select non-clinical work.
• Ensure appropriate statistical methods and regulatory compliance in trials.
• Oversee CRO/contract staff and review budgets and contracts.
• Act as project statistician and represent statistics in regulatory meetings.
• Develop and implement processes to improve efficiency and productivity.
• Prepare clinical study protocols, SAPs, and regulatory submissions.

Skills

Leadership

Statistical thinking

Communication

Education

Ph.D. in Biostatistics (or related field)

Tools

SAS

Job description

BioCryst Pharmaceuticals, Inc. is seeking an Exec.

Director, Biostatistics to lead the design and analysis of clinical studies from Phase I to IV, oversee outsourcing, and drive advanced statistical methods in support of regulatory submissions. The role requires deep biostatistical expertise, vendor management, and the ability to communicate complex concepts clearly to regulatory and nontechnical audiences.