Senior Director, Head of Statistical Programming

Key Responsibilities

• Define and lead the vision, standards, operational strategy, and long-term scalability roadmap for the Statistical Programming function
• Build, mentor, and develop internal statistical programming capabilities through strategic hiring, coaching, resource planning, and team leadership
• Oversee the development, validation, review, and delivery of SDTM datasets, ADaM datasets, tables, listings, figures (TLFs), and related programming deliverables across clinical development programs
• Ensure all programming deliverables meet internal quality standards, CDISC compliance requirements, and applicable regulatory expectations for global submissions
• Provide technical and operational oversight for programming activities supporting clinical trials, regulatory submissions, publications, safety analyses, and ad hoc data requests
• Drive programming strategy and readiness for regulatory interactions and submissions, including FDA, EMA, PMDA, NDA, BLA, and MAA activities
• Establish, maintain, and optimize programming processes, standards, SOPs, macros, validation frameworks, and data governance workflows to improve consistency, efficiency, scalability, and inspection readiness
• Lead and oversee relationships with external CROs, statistical programming vendors, and independent contractors, including scope management, quality oversight, timeline accountability, and budget management
• Partner closely with Biostatistics, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and Clinical Development teams to ensure alignment on study timelines, deliverables, and data quality expectations
• Contribute to submission strategy discussions, inspection readiness activities, and responses to regulatory questions related to programming deliverables and data standards
• Evaluate and implement innovative technologies, tools, and automation opportunities to enhance programming efficiency and reproducibility
• Support organizational growth initiatives and contribute to broader departmental strategy and operational planning efforts

Qualifications

• Bachelor’s, Master’s, or PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related quantitative discipline
• Typically, 12+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry, including leadership experience supporting clinical development programs
• Demonstrated experience leading statistical programming activities across multiple phases of clinical development, including late-stage studies and regulatory submissions
• Deep expertise in CDISC standards, including SDTM and ADaM implementation
• Expert-level proficiency in SAS required; familiarity with R and/or Python strongly preferred
• Strong understanding of clinical trial processes, regulatory requirements, and industry best practices related to statistical programming and submission deliverables
• Proven experience managing external CROs, vendors, and outsourced programming models within a matrixed environment
• Demonstrated ability to establish scalable programming standards, processes, and operational infrastructure within a growing organization
• Prior experience supporting FDA, EMA, PMDA, NDA, BLA, and/or MAA submissions strongly preferred
• Excellent leadership, communication, collaboration, and organizational skills with the ability to influence across cross-functional teams and executive stakeholders
• Ability to thrive in a fast-paced, highly collaborative, and evolving biotechnology environment

Work Environment