Executive Director, Biometrics

🕒 4 dias atrás

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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BioCryst Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals em 2023-04

Healthcare • Consulting • Logistics

A BioCryst Pharmaceuticals, Inc. é uma empresa global de biotecnologia focada na descoberta, desenvolvimento e comercialização de novos tratamentos orais com pequenas moléculas e proteínas para doenças raras, notadamente o angioedema hereditário (AEH). Fundada em 1986, a BioCryst utiliza design de medicamentos guiado por estrutura, química medicinal e tecnologias avançadas para desenvolver medicamentos de primeira classe ou superiores, e trabalha em estreita colaboração com pacientes, grupos de apoio e parceiros globais para levar os tratamentos ao mercado.

Descrição

• Lead the conduct and analysis of BioCryst-sponsored clinical studies from Phase I to Phase IV and selected non-clinical studies • Provide Biometrics support for clinical studies, selected non-clinical studies, and Medical Affairs • Ensure relevance and adequacy of statistical methods and conformance to regulatory guidelines and Good Clinical Practice • Contribute to clinical development strategies, development programs, and study design • Oversee CRO and contract staff performing outsourced operational activities • Review and approve contracts, work orders, and invoices within delegated authority • Act as project statistician for an individual project • Participate in FDA and other regulatory agency meetings as the company’s biostatistical spokesperson • Define, create, and implement organization-wide processes focused on efficiency and productivity • Define, monitor, and evaluate relevant performance metrics • Author and review statistical and biometrics sections of protocols, statistical analysis plans, data management plans, regulatory documents, NDAs, MAAs, regulatory responses, abstracts, and manuscripts • Ensure accuracy of clinical trial data in public corporate communications, including press releases, presentations, SEC filings, abstracts, and manuscripts • Monitor the quality audit process for public clinical trial communications • Communicate technical concepts to technical, regulatory, and broader nontechnical audiences • Identify, evaluate, and implement new biostatistics and programming processes and technologies • Develop and align outsourcing strategy with Clinical Development goals • Perform additional duties as assigned

🎯 Requisitos

• 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 sufficient to provide oversight of statistical programming and ability to program as needed • Strong leadership and interpersonal skills • NDA filing experience as a key contributor to one or more successful product approvals • Proven expertise in 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 • Hands-on approach, including performing analyses when necessary • Excellent written and verbal communication skills • Ability to work well in a collegial environment and challenge the status quo • Experience with European and Japanese regulatory agencies • Formal expertise and experience in Bayesian and frequentist statistics • Flexible scheduling and ability to travel internationally • Responsiveness and ability to prioritize effectively

🏖️ Benefícios

• Equal employment opportunity protections • Protected Veterans/Individuals with Disabilities status protections • Flexible scheduling • Opportunity to work on innovative first-in-class or best-in-class therapeutics • International travel opportunities