SVP, Head of Biometrics & Data Sciences

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.

The Senior Vice President, Biometrics & Data Sciences is a key member of the Research & Development Leadership Team and serves as the strategic leader for Biostatistics, Statistical Programming, Data Management, Data Sciences, Clinical Analytics, and Advanced Quantitative Methodologies across the BioCryst portfolio.

Reporting directly to the Chief Research & Development Officer, this executive will provide scientific, operational, and regulatory leadership supporting assets from discovery and translational research through global regulatory approval and lifecycle management.

This individual will be responsible for establishing and executing a modern Data Sciences vision that integrates statistical innovation, automation, machine learning, artificial intelligence, predictive analytics, and quantitative decision-making to improve the probability of technical and regulatory success while accelerating development timelines.

The successful candidate will be a forward-thinking leader with deep expertise in clinical drug development, extensive health authority interactions, and a demonstrated track record of leading global biometrics organizations supporting both early- and late-stage development programs.

Key Responsibilities

Strategic Leadership

·       Lead and evolve BioCryst's global Biometrics & Data Sciences organization

·       Key leader to make decisions on the CRO selection and work with the CRO to ensure quality deliverables

·       Serve as a strategic advisor to the CRDO, Executive Leadership Team, and development teams on quantitative development strategy.

·       Develop and implement a long-term vision for AI-enabled drug development and data-driven decision making

·       Working with the Chief Innovation Officer, ensure an integrated AI vision for R&D and company

·       Build organizational capabilities that leverage automation, machine learning, generative AI, simulation, and advanced statistical methodologies across the development continuum.

Clinical Development Leadership

·       Provide statistical and quantitative leadership for programs from first-in-human studies through global registration and post-marketing commitments.

·       Guide innovative trial design strategies including: Adaptive designs, Bayesian methodologies, Platform trials, Seamless development approaches, External control arms, Rare disease development strategies, etc

·       Lead statistical planning and execution for pivotal studies supporting regulatory submissions worldwide.

·       Ensure the highest scientific standards in protocol development, statistical analysis plans, data interpretation, and clinical study reporting.

Regulatory Leadership

·       Serve as the senior Biometrics representative in interactions with FDA, EMA, PMDA, MHRA, Health Canada and Other global regulatory agencies

·       Lead quantitative strategy for: INDs, BLAs, NDAs, MAAs and Label negotiations

·       Drive health authority engagement on innovative methodologies, estimands, modeling approaches, and novel trial designs.

·       Ensure regulatory compliance with global standards and emerging regulatory expectations for advanced analytics and AI.

Data Science, AI & Innovation

·       Champion transformation of clinical development through advanced data science approaches.

·       Establish frameworks for responsible deployment of Artificial Intelligence, Machine Learning, Deep Learning, Predictive Analytics, Natural Language Processing , Real-World Data and Evidence

·       Apply advanced analytics to enhance: Patient selection, Trial optimization, Site selection, Recruitment forecasting, Risk-based monitoring, Endpoint analysis and Regulatory submissions

·       Partner across R&D to embed quantitative and computational thinking into decision-making processes.

Organizational Leadership

·       Recruit, develop, and retain world-class talent across Biometrics and Data Sciences.

·       Foster a high-performance culture emphasizing innovation, accountability, collaboration, and scientific excellence.

·       Lead internal and external resources, including CRO and strategic vendor partnerships.

·       Build capabilities and succession plans that support BioCryst's long-term growth objectives.

·       Promote effective cross-functional collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Medicine, Clinical Pharmacology, Medical Writing, and Quality functions.

Qualifications

Education

·       PhD required in Statistics or Biostatistics or Applied Mathematics or closely related discipline

Experience

·       Minimum 15 years of progressive leadership experience within the pharmaceutical, biotechnology, or life sciences industry.

·       Significant experience leading global biometrics organizations.

·       Demonstrated success supporting both early- and late-stage clinical development.

·       Extensive experience in rare disease drug development strongly preferred.

·       Broad therapeutic area experience spanning multiple disease areas.

·       Proven track record of multiple successful regulatory submissions and approvals.

·       Extensive direct interactions with FDA, EMA, and other major global health authorities.

·       Experience implementing innovative trial designs and advanced quantitative methodologies.

·       Demonstrated success leading organizational transformation initiatives involving AI, automation, and advanced analytics.

Leadership Competencies

·       Visionary and forward-thinking leader.

·       Exceptional communication and influencing skills.

·       Strong executive presence and ability to communicate complex quantitative concepts to diverse audiences.

·       Strategic thinker with strong business acumen.

·       Proven ability to inspire and lead high-performing global teams.

·       Collaborative leadership style with a commitment to scientific rigor and innovation.

·       Passion for advancing therapeutic innovation and improving outcomes for patients with rare diseases.

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

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.