VP, 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 Vice President, Biostatistics within BioCryst Pharmaceuticals, this individual is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct and analysis of BioCryst-sponsored studies. Having managerial, technical and vendor management responsibilities, this role is responsible for the appropriate use of strategic statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics. S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies that align Biostatistics responsibilities.  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.    ESSENTIAL DUTIES & RESPONSIBILITIES: •       Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all BioCryst-sponsored clinical development activities and selected nonclinical studies. •       Oversees statistical activities of regulatory submissions including NDA/BLAs. •       Ensures clinical data processing conformance to relevant regulatory guidelines and Good Clinical Practice. •       Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design. •       Lead and manage junior biostatistics staff. •       Selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities. •       Utilizes statistical software (SAS, EAST, R) for internal ad hoc requests for data analysis, samples sizes, etc. •       Participation in clinical development/product management teams in support of organizational objectives. •       Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics. •       Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement. •       Definition, monitoring,…