Exec. Director, Biostatistics

At Bio Cryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries.

We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at  or follow us on Linked In and Instagram.

As Exec. Director, Biostatistics, this individual leads the conduct and analysis of all Bio Cryst-sponsored clinical studies from Phase I to Phase IV as well as selected non-clinical studies. The role requires technical expertise as well as vendor management capabilities. The individual in this role is responsible for the appropriate use of statistical thinking and methods and conformance to principles of GCP, as applicable to biostatistics and programming.

S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies related to biostatistics and programming as well as outsourcing strategy, in alignment with the goals of Biostatistics & Data Science.

S/he may act as project statistician for an individual project. Performance in this role relies on an extensive experience base in study design, regulatory strategy and programming, sound judgment to plan and accomplish goals, and an ability to lead and direct the work of others. A wide scope of creativity and latitude is expected.

• Responsible for Biostatistics support of Bio Cryst-sponsored clinical studies as well as selected non-clinical studies and Biostatistics support of Medical Affairs.
• Ensures the relevance and adequacy of statistical methods employed in Bio Cryst-sponsored clinical development activities and selected nonclinical studies.
• Ensures conformance to relevant regulatory guidelines and Good Clinical Practice.
• Ensures that Biostatistics effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.
• Responsible for Biostatistics oversight of CRO/contract staff for performance of outsourced operational activities. Reviews and approves contracts, work orders, and invoices within grant of authority.
• Act as project statistician for an individual project.
• Participation in FDA and other regulatory agency meetings as the Company's spokesperson for biostatistical topics.
• Thinks outside of the regulatory biostatistics box (e.g. maximum learning from phase 2 experiments regardless of pre-specified SAP, experience in Phase 3b/4 design and analysis to maximize a product's life cycle).
• Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement.
• Definition, monitoring, and evaluation of relevant performance metrics.
• Author/ reviewer of relevant sections of all critical documents required to support development of Company's products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts.
• Responsible for accuracy of data included in public corporate communications of Bio Cryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts.…