Director, Statistical Programming

BioCryst Pharmaceuticals, Inc.

. Provide technical programming strategy for complex studies, programs, and regulatory submissions .

Posted 11/2/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in SAS programming and statistical analysis for clinical trials, ensuring regulatory compliance and quality in programming deliverables. Capable of leading complex studies and managing CRO relationships while providing technical direction and mentorship.

Highest-signal resume keywords

SAS ProgrammingStatistical AnalysisRegulatory ComplianceClinical Data ManagementTechnical Leadership

ATS Keywords

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Hard Skills

SAS ProgrammingSQLDATA StepMacro ProgrammingStatistical Analysis ProceduresPerformance OptimizationData VisualizationMetadata-Driven ProgrammingRPython

Soft Skills

Excellent Communication SkillsMentoringProblem-SolvingPrioritization

Tools & Technologies

Clinical Data-Review ToolsValidated Automation Frameworks

Industry Keywords

21 CFR Part 11Good Clinical PracticeNDA/BLA SubmissionsSDTMADaMDefine.xmlAnnotated CRFsRegulatory Information RequestsClinical DevelopmentPharmaceutical Industry

Tech Stack

Tools & technologies

PythonSQL

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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