VP, Biostatistics

COMPANY:

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 Vice President, Biostatistics within Bio Cryst Pharmaceuticals, this individual is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct and analysis of Bio Cryst-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.

• Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all Bio Cryst-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, 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 and accountable for accuracy of all 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. Responsible for monitoring of quality audit process for those communications.
• Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor.

• Ph.D. in Biostatistics (or related field) with at least 18 years' experience in the pharmaceutical industry, 10 or more years' experience in the design, analysis and interpretation of clinical trials or an equivalent combination of education and experience. At least 5 years of people management and leadership role.
• Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making.
• NDA/BLA filing experience: key contributor to multiple successful product approvals.
• Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, including development and accountability for relevant quality management systems.
• Experience…