Director, Statistical Programming Standards & Infrastructure

Role Summary

The Director of Statistical Programming Standards & Infrastructure provides strategic leadership and oversight for the development, implementation, and maintenance of global statistical programming standards, tools, and infrastructure. This role ensures compliance with regulatory requirements, industry standards (e.g., CDISC), and internal quality processes. The Director will partner with cross-functional teams, including Biostatistics, Clinical Data Management, and IT, to drive innovation, efficiency, and consistency in statistical programming deliverables across studies and submissions.

Responsibilities

• Define and execute the vision for statistical programming standards and infrastructure aligned with organizational goals.
• Establish governance for global programming standards, tools, and processes.
• Oversee creation, validation, and lifecycle management of global macros, standard programs, and reusable code libraries.
• Ensure adherence to SDLC principles for all programming tools and infrastructure components.
• Drive initiatives to enhance automation, scalability, and efficiency in programming workflows.
• Collaborate with IT to maintain robust, secure, and compliant programming environments.
• Ensure deliverables meet CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA).
• Oversee quality control processes for CRO deliverables and internal outputs, including datasets and TLFs.
• Partner with Biostatistics, Clinical Data Management, and other stakeholders to align standards and infrastructure with clinical development needs.
• Serve as subject matter expert for programming standards during audits and regulatory inspections.
• Lead and mentor a team of statistical programmers and standards specialists.
• Manage resource allocation, training and career development for team members.
• Identify emerging technologies and best practices to advance programming capabilities.
• Champion process improvements and standardization initiatives across the organization.

Qualifications

• BS/BA degree in a related discipline and a minimum of 13 years of relevant experience; or,
• MS/MA degree in a related discipline and a minimum of 11 years of relevant experience; or,
• PhD in a related discipline and a minimum of 8 years of relevant experience; or,
• Equivalent combination of education and experience.
• Extensive experience in pharmaceutical/biotech statistical programming, including NDA/BLA submissions.
• Proven track record in developing and implementing programming standards and infrastructure.
• Strong proficiency in SAS/Base, SAS/Stat, SAS/Macro; programming experience in R and Python is a plus; experience with CDISC standards and SDLC.
• Familiarity with oncology clinical trials preferred.

Skills

• Strategic thinking with ability to translate vision into actionable plans.
• Strong leadership and team management skills.
• Good managerial and organizational skills.
• Excellent communication and collaboration abilities.
• Knowledge of appropriate FDA regulations, industry standards and guidance documents.
• Understands clinical research process, trial designs, and the development of protocols and analysis plans.
• Experience authoring SOPs and work instructions.
• Works on highly complex problems requiring strategic analysis and innovative solutions.
• Influences organizational policies and practices related to statistical programming standards and infrastructure.
• Networks extensively with internal and external stakeholders to drive alignment and adoption of standards.