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.
#J-18808-LjbffrExec. Director, Biometrics in nc at Unknown Company
This position is listed as full time and onsite.