Director, Statistical Programming

🕒 Novembro 2

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 10%

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• Sem salário divulgado.

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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

• Provide technical programming strategy for complex studies, programs, and regulatory submissions • Provide technical direction, mentoring, and peer consultation • Assess programming scope, complexity, resource needs, critical-path activities, and delivery risks • Lead statistical programming for assigned studies, development programs, and submission workstreams • Ensure completeness, accuracy, traceability, reproducibility, and regulatory readiness of programming deliverables • Oversee outsourced programming, including specifications, deliverable review, issue resolution, risk tracking, and vendor accountability • Review eCRFs, annotated CRFs, data management plans, edit-check specifications, statistical analysis plans, dataset specifications, and TLF shells • Develop and validate complex tables, listings, figures, nonstandard analyses, visualizations, and regulatory outputs • Collaborate with Biostatistics, Data Management, and other functions on clinical data conformance and Good Clinical Practice • Provide technical consultation and training to programmers, medical monitors, scientists, and medical writers • Select and onboard CROs and contractors and manage assigned programming deliverables • Maintain inspection-ready programming documentation under SOPs and regulatory expectations • Contribute to process definition, standards, automation, and implementation; author or update SOPs, work instructions, templates, and technical guidance • Monitor quality, timeliness, and vendor performance indicators and implement corrective or preventive actions • Communicate complex programming, data, and submission issues to technical, cross-functional, executive, and regulatory audiences • Perform other duties as assigned

🎯 Requisitos

• M.S. in Biostatistics, Computer Science, or a related field with at least 10 years of pharmaceutical or biotechnology industry experience in statistical programming and analysis of clinical trial data, or an equivalent combination of education and experience • Extensive hands-on SAS programming experience • Prior success as a senior technical individual contributor leading complex studies, programs, or submission workstreams without formal people-management authority • Expert-level SAS programming, including advanced DATA step, SQL, macro programming, analysis procedures, debugging, performance optimization, and production of graphics • Experience across multiple phases of clinical development preferred; early-phase and clinical pharmacology experience helpful but not required • Working knowledge of 21 CFR Part 11, GCP, and regulatory expectations for validated systems, electronic records, traceability, and controlled programming environments • Experience with clinical data-review and visualization tools preferred • Experience with R, Python, metadata-driven programming, or validated automation frameworks highly desirable • Experience managing CRO and contractor programming deliverables, including scope definition, technical review, timeline and risk management, issue escalation, quality oversight, and final acceptance • Expertise in statistical programming practices and clinical data management processes, including robust QC, independent validation, reproducible workflows, and inspection-ready documentation • Knowledge of clinical development and regulatory requirements, including NDA/BLA submissions, SDTM, ADaM, define.xml, annotated CRFs, reviewers guides, integrated summaries, submission TLFs, and regulatory information requests • Understanding of Biostatistics, Data Management, Clinical Development, Medical Writing, Regulatory Affairs, Pharmacovigilance, and Clinical Pharmacology roles • Technical leadership and cross-functional influence • Ability to independently program, validate, troubleshoot, and deliver complex analyses and submission components under compressed timelines • Excellent written and verbal communication skills • Ability to prioritize competing study, submission, and vendor deliverables

🏖️ Benefícios

• Equal employment opportunity employer • Protected Veterans/Individuals with Disabilities • Compliance with federal, state, and local employment law

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