Executive Director, Biostatistics & Clinical Data Science

BioCryst Pharmaceuticals, Inc.; Durham, Boston (NC, MA); On-site; CAD 180,000 - 260,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking an Exec. Director of Biostatistics to lead statistics across Phase I–IV clinical studies and select non-clinical work. The role emphasizes statistical thinking, GCP conformance, and advancing new processes in biostatistics and programming.

Strong vendor management and global collaboration are essential. The position requires a Ph.D. in Biostatistics with 12+ years in pharma, including NDA experience, and expertise in Bayesian and frequentist methods.

Qualifications

• Ph.D. in Biostatistics with 12+ years in pharma or biotech.
• Strong leadership and interpersonal skills.
• Experience with NDA filings and regulatory submissions.
• Expertise in Bayesian and frequentist statistics and study design.

Responsibilities

• Provide biostatistics leadership for BioCryst-sponsored studies (Phase I–IV).
• Ensure appropriate statistical methods and regulatory conformance (GCP).
• Oversee CRO/contract staff and outsourcing contracts.
• Contribute to development strategies, SAPs, and regulatory dossiers.
• Communicate complex statistics to technical and non-technical audiences.

Skills

Biostatistics leadership

SAS programming

Clinical trial design

Regulatory knowledge

Bayesian statistics

Frequentist statistics

Data management oversight

Vendor management

Communication skills

International travel

Education

Ph.D. in Biostatistics

Tools

SAS

Job description

BioCryst Pharmaceuticals, Inc. is seeking an Exec. Director of Biostatistics to lead statistics across Phase I–IV clinical studies and select non-clinical work. The role emphasizes statistical thinking, GCP conformance, and advancing new processes in biostatistics and programming.

Strong vendor management and global collaboration are essential. The position requires a Ph.D. in Biostatistics with 12+ years in pharma, including NDA experience, and expertise in Bayesian and frequentist methods.