Executive Director, Statistical Programming

🕒 Setembro 25

🌲 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

• Develop a vision and strategy for BioCryst’s statistical programming group • Oversee statistical programming activities for all BioCryst clinical trials, including in-house and outsourced activities • Lead analyses for regulatory submissions, safety review, scientific publications, and medical affairs • Manage statistical programmers and ensure strong technical capabilities for complex algorithms and regulatory submission packages • Define software and systems needs for the Biometrics and Data Science group in partnership with Information Technology • Keep abreast of industry best practices and standards • Participate in capacity planning and departmental growth • Ensure statistical programming leadership and consistent support for all clinical study teams • Ensure completeness, accuracy, and timeliness of statistical programming for clinical development activities and selected nonclinical studies • Oversee outsourced statistical programming and meet regularly with CRO counterparts • Review eCRFs, annotated CRFs, data management plans, edit check specifications, and statistical analysis plans • Ensure accurate programming of tables, listings, and figures • Collaborate with data management on regulatory guideline and Good Clinical Practice conformance • Provide specialty SAS programming and customized line listings for clinical data review • Provide training and support on internal data review tools • Select, direct, and supervise CRO/contract staff • Maintain study documentation according to SOPs and audit standards • Define, create, and implement organization-wide processes focused on efficiency and productivity • Author SOPs related to statistical programming • Monitor and evaluate performance metrics • Communicate technical concepts to technical, regulatory, and broader nontechnical audiences • Perform other duties as assigned

🎯 Requisitos

• M.S. in Biostatistics, Computer Science or related field with at least 15 years’ experience in the pharmaceutical industry, with relevant experience in the analysis of clinical trial data, or an equivalent combination of education and experience • Extensive SAS programming experience • Prior experience in NDA/BLA submissions to successfully support product approvals • Prior experience in managing permanent staff • Experience with SAS/Graph and/or providing quality graphics for scientific publications • Understanding of 21CFR Part 11 standards • Experience with tools to support viewing of data by medical monitors and others • Prior experience with managing outsourced statistical programming work • Proven expertise in statistical programming disciplines, practices and procedures • Understanding of clinical data management processes • Demonstrated knowledge of the clinical development process and relevant regulatory guidelines and requirements • Understanding of the roles and responsibilities of Biostatistics and Data Management • Leadership skills both functional and cross functional • Hands-on approach to statistical analyses • Excellent written and verbal communication skills • Ability to work well in a collegial environment and challenge the status quo • Responsiveness and ability to prioritize effectively • Early phase clinical trials and clinical pharmacology endpoints experience is helpful but not required • Knowledge of clinical database design would be helpful

🏖️ Benefícios

• 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 • Compliance with all federal, state and local law