Director, Statistical Programming

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🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👔 Director

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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

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