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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 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 (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 BioCryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts. Responsible for monitoring 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.
All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
Ph.D. in Biostatistics (or related field) with at least 12 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. Deep understanding of SAS programming is sufficient to provide oversight of statistical programming and ability to program as needed. Management experience preferred.
Strong leadership and interpersonal skills.
NDA filing experience: key contributor to one or more successful product approvals.
Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, programming, and clinical data management, including development and accountability for relevant quality management systems.
Demonstrated knowledge of the clinical development process and relevant regulatory guidelines and requirements.
Experience with Data Monitoring Committees and\or study steering committees.
Takes a hands-on approach (e.g. will do analyses him/herself when necessary).
Excellent written and verbal communication skills.
Proven team player with ability to work well in a collegial environment: willing to challenge the status quo.
Experience with European and Japanese regulatory agencies.
Formal expertise and experience in Bayesian statistics as well as frequentist statistics.
Experience supporting medical affairs and post-marketing studies is an added benefit.
Flexible scheduling and ability to travel internationally.
“Small-company attitude” that embraces change within a high-risk environment.
Responsiveness and ability to prioritize effectively.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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