Director, Statistical Programming

🕒 vor 7 Tagen

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 10%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Warum dieser Wert:

• Seit 8 Tagen offen.
• Stellen bei diesem Unternehmen werden meist in 40 Tagen besetzt.
• Kein Gehalt angegeben.

Jetzt Bewerben

Ähnliche Remote-Jobs finden

BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

💰 €450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals im 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. ist ein global tätiges Biotechnologieunternehmen, das sich auf die Entdeckung, Entwicklung und Vermarktung neuartiger oraler kleiner Moleküle und Proteintherapeutika für seltene Krankheiten, insbesondere hereditäres Angioödem (HAE), konzentriert. Seit seiner Gründung im Jahr 1986 nutzt BioCryst strukturgeleitetes Wirkstoffdesign, medizinische Chemie und fortschrittliche Technologien, um erstklassige oder best-in-class Medikamente zu entwickeln, und arbeitet eng mit Patienten, Interessengruppen und globalen Partnern zusammen, um Behandlungen auf den Markt zu bringen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen