Exec. Director, Biostatistics

COMPANY: At BioCryst, 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 www.biocryst.com  or follow us   on LinkedIn  and Instagram . JOB SUMMARY: As Exec. Director, Biostatistics, this individual leads the conduct and analysis of all BioCryst-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.   and direct the work of others. A wide scope of creativity and latitude is expected.        ESSENTIAL DUTIES & RESPONSIBILITIES: •       Responsible for Biostatistics support of BioCryst-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 BioCryst-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…