ObjectiveWe are seeking a Director of Biostatistics Programming to lead and oversee the biostatistics programming function in support of clinical development programs. This role is responsible for setting strategic direction, ensuring high-quality statistical programming deliverables, and managing resources, processes, and standards across clinical development programs. The Director will partner closely with biostatistics, data management, clinical development, regulatory, and external vendors to deliver SDTM, ADaM, and TFLs that support study milestone analyses, publications, and regulatory submissions. This position offers the opportunity to shape programming strategy in a fast-paced oncology and nuclear medicine environment and to contribute directly to regulatory success and data-driven decision-making.Essential FunctionsLeadership and StrategyLead and manage the biostatistics programming function, including governance and quality oversight of internal programmers and external CRO/vendor programming activities.Define and maintain statistical programming standards, processes, and best practices to ensure consistency, quality, inspection readiness, and regulatory compliance across programs.Provide strategic input into clinical development plans, timelines, and resourcing from a programming and data delivery perspective.Mentor, develop, and performance-manage biostatistics programming staff, fostering technical excellence and career growth.Serve as the primary programming representative on cross-functional study teams and program-level governance forums.Represent the biostatistics programming function as a subject matter expert in regulatory interactions, as appropriate.Statistical Programming OversightOversee the development, validation, and maintenance of statistical programs for clinical trial data analysis using SAS and/or R in accordance with CDISC standards.Ensure timely and accurate production of TFLs and data visualizations for study milestone analyses, publications, regulatory submissions, and internal decision-making.Review and approve programming deliverables, including analysis datasets, TFLs, define.xml, reviewer’s guides, and supporting programming documentation.Provide hands-on programming support and technical troubleshooting for complex, novel, or high-impact analyses and high-priority deliverables, as needed.Partner with biostatisticians to ensure accurate and efficient implementation of Statistical Analysis Plans (SAPs), including derivation specifications and analysis requirements.Lead inspection readiness activities related to statistical programming deliverables, including documentation, traceability, and responses to regulatory inspection findings.Automation, Innovation, and Process ImprovementDrive the development and adoption of reusable macros, functions, templates, and automated workflows to improve efficiency, quality, reproducibility, and consistency.Oversee the use of SAS, R, and other tools to modernize analysis pipelines and reporting processes.Identify and implement continuous improvement initiatives related to programming efficiency, data quality, documentation, and vendor performance.QualificationsEducation / ExperienceMaster’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative field (PhD a plus).10+ years of industry experience in statistical programming in biotech/pharma/CRO, including people leadership and/or functional leadership.Demonstrated experience leading late-phase (Phase 3) study deliverables and supporting regulatory submissions (e.g., NDA/BLA), including oversight of vendor/CRO programming.Experience supporting oncology programs and/or complex data sources (e.g., imaging, biomarkers, radiopharmaceutical data) preferred.Knowledge / Skill / AbilityExpert knowledge of clinical trial statistical programming and deliverables (SDTM, ADaM, TFLs) and associated documentation (define.xml, reviewer’s guides).Advanced proficiency in SAS; working proficiency in R and/or other modern programming tools used for clinical reporting and analysis automation.Thorough understanding of ICH/GCP principles, regulatory submission expectations, and inspection readiness requirements for statistical programming.Ability to establish and govern programming standards, validation practices, and traceability across studies and vendors.Proven skill in leading, mentoring, and developing statistical programming teams, including workload planning, prioritization, and performance management.Strong cross-functional communication skills to translate statistical requirements into clear specifications and drive timely delivery of high-quality outputs.Demonstrated ability to manage CRO/vendor deliverables, including oversight of quality, timelines, issue resolution, and continuous process improvement.
