Exec. Director, Biometrics

Scorpion Therapeutics; North Carolina; On-site; USD 180,000 - 260,000; Full time

Job summary

BioCryst seeks an Executive Director, Biometrics to lead the design, analysis, and oversight of Phase I–IV trials, and select non-clinical studies. You will guide statistical strategy and ensure GCP compliance across international studies.

The role requires a PhD in Biostatistics, 12+ years in pharma, and strong leadership with NDA contributions, plus expertise in Bayesian and frequentist methods using SAS.

Qualifications

• PhD in Biostatistics or related field required.
• 12+ years in pharma or biotech.
• Deep expertise in clinical trial design.
• Experience with regulatory submissions is a plus.
• Strong leadership and NDA contributions.

Responsibilities

• Ensure appropriate statistical methods for phase I–IV studies.
• Maintain regulatory compliance (GCP).
• Contribute to clinical development strategies.
• Oversee CROs and act as project statistician.
• Participate in regulatory meetings.
• Author and review key documents (protocols, SAPs, submissions).
• Support scientific communication.

Skills

Biostatistics

Clinical trial design

Leadership

SAS

Education

PhD in Biostatistics or related field

Tools

SAS

Job description

Role: Executive Director, Biometrics

leading design, analysis, and oversight of all Phase I-IV clinical studies and select non-clinical studies at BioCryst, primarily in rare diseases like hereditary angioedema.

Responsibilities

• ensure appropriate statistical methods
• regulatory compliance (GCP)
• contribute to clinical development strategies
• oversee CROs
• act as project statistician
• participate in regulatory meetings
• author and review key documents (protocols, SAPs, regulatory submissions)
• and support scientific communication.

Qualifications

• Ph.D. in Biostatistics or related field
• 12+ years in pharma
• deep expertise in clinical trial design
• statistical programming (SAS)
• Bayesian and frequentist methods
• with leadership experience and NDA contribution.

High Value

• rare disease therapeutics
• early to late-phase trials
• regulatory interactions (FDA, EU, Japan)
• GxP compliance
• biometrics leadership
• post-marketing studies
• international travel
• and cross-functional collaboration.

Work Setup

flexible, international travel expected.