The Director will lead through technical expertise, cross-functional influence, and rigorous oversight of contractors and CRO programming deliverables. Success requires sound judgment, practical problem solving, and the ability to work hands-on in a fast-paced environment while maintaining inspection-ready quality and regulatory compliance.
ESSENTIAL DUTIES & RESPONSIBILITIES
Provides technical programming strategy for assigned complex studies, programs, and regulatory submissions, including fit-for-purpose use of programming languages, tools, standards, and systems.
Provides technical direction, mentoring, and peer consultation as needed.
Assesses programming scope, complexity, resource needs, critical-path activities, and delivery risks for assigned studies and submissions; recommends an appropriate mix of internal, contractor, and CRO support.
Acts as the statistical programming lead for assigned studies, development programs, and submission workstreams, ensuring consistent, timely, and technically rigorous support.
Ensures completeness, accuracy, traceability, reproducibility, and regulatory readiness of statistical programming deliverables for assigned BioCryst-sponsored clinical development activities and selected nonclinical studies.
Provides hands-on oversight of outsourced programming, including defining specifications and deliverable expectations, reviewing CRO or contractor work, resolving technical issues, tracking risks and dependencies, and holding vendors accountable for quality and timelines.
Performs expert programming review of eCRFs, annotated CRFs, data management plans, edit-check specifications, statistical analysis plans, dataset specifications, and TLF shells to ensure required data are collected, analysis-ready, traceable, and fit for the intended analyses.
Develops and validates complex, high-quality tables, listings, and figures, including nonstandard analyses, advanced data visualizations, and time-critical regulatory outputs.
Collaborates with Biostatistics, Data Management and other functions to support clinical data conformance with applicable regulatory requirements and Good Clinical Practice, including specialized programming and customized review listings as needed.
Provides technical consultation and training to programmers, medical monitors, scientists, and medical writers on programming standards, data review tools, analysis datasets, and interpretation of outputs.
Participates in selection and onboarding of CROs and contractors and manages their assigned programming deliverables through clear work orders, specifications, review cycles, issue resolution, and acceptance criteria, without direct personnel-management responsibility.
Maintains complete, accurate, and inspection-ready programming documentation in accordance with SOPs, work instructions, and regulatory expectations.
Contributes expert input to organization-wide process definition, standards, automation, and implementation, with a continuous focus on quality, efficiency, reproducibility, and productivity; authors or updates statistical programming SOPs, work instructions, templates, and technical guidance.
Monitors study- and submission-level quality, timeliness, and vendor performance indicators; identifies trends and implements corrective or preventive actions for assigned work.
Communicates complex programming, data, and submission issues clearly to technical, cross-functional, executive, and regulatory audiences without loss of rigor.
Other duties as assigned.
EXPERIENCE & QUALIFICATIONS
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 is required.
Prior success as a senior technical individual contributor leading complex studies, programs, or submission workstreams without reliance on formal people-management authority.
Expert-level SAS programming skills, including advanced DATA step, SQL, macro programming, analysis procedures, debugging, performance optimization, and production of high-quality graphics for regulatory submissions and scientific publications.
Experience across multiple phases of clinical development is preferred; experience with early-phase studies and clinical pharmacology endpoints is 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 is preferred. Experience with R, Python, metadata-driven programming, or validated automation frameworks is highly desirable.
Demonstrated experience managing CRO and contractor programming deliverables, including scope definition, technical review, timeline and risk management, issue escalation, quality oversight, and final acceptance.
Proven expertise in statistical programming practices and clinical data management processes, including robust QC, independent validation, reproducible workflows, and inspection-ready documentation.
Demonstrated knowledge of clinical development and applicable regulatory requirements, with substantial hands-on experience supporting NDA and/or BLA submissions, including SDTM, ADaM, define.xml, annotated CRFs, reviewers guides, integrated summaries, submission TLFs, and regulatory information requests.
Strong understanding of the roles and responsibilities of Biostatistics, Data Management, Clinical Development, Medical Writing, Regulatory Affairs, Pharmacovigilance, and Clinical Pharmacology. Knowledge of clinical database design is helpful.
Demonstrated technical leadership and cross-functional influence, including the ability to establish programming approaches, make defensible technical decisions, and drive resolution of complex data and analysis issues.
Takes a consistently hands-on approach and is capable of independently programming, validating, troubleshooting, and delivering complex analyses and submission components under compressed timelines.
Excellent written and verbal communication skills.
Proven collaborator who works effectively in a collegial environment, constructively challenges the status quo, and influences outcomes through expertise and sound judgment.
Embraces change, ambiguity, accountability, and practical problem solving in a high-risk development environment.
Exceptional responsiveness and ability to prioritize competing study, submission, and vendor deliverables effectively.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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