Director, Statistical Programming

🕒 il y a 4 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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BioCryst Pharmaceuticals, Inc.

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501 - 1000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €450 000 000 Post-IPO Debt - BioCryst Pharmaceuticals en 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. est une entreprise mondiale de biotechnologie spécialisée dans la découverte, le développement et la commercialisation de nouvelles petites molécules orales et de thérapies protéiques pour les maladies rares, notamment l'œdème angioneurotique héréditaire (OAH). Fondée en 1986, BioCryst utilise la conception de médicaments guidée par la structure, la chimie médicinale et les technologies avancées pour développer des médicaments de première classe ou de meilleure classe, et travaille en étroite collaboration avec les patients, les associations de patients et les partenaires mondiaux pour mettre les traitements sur le marché.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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

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