Lead Statistical Programming Architect – Macro, Automation & AI

In this role, you will shape the long-term programming technology strategy for Global Biometry and lead technical initiatives across Oncology, Rare Disease and Neurosciences. You will partner with cross-functional teams to ensure compliant, scalable, and efficient data analysis and reporting. Your work will drive automation, standardization, and innovation in statistical programming and clinical data analysis. This is an opportunity to influence global Biometry technology and contribute to regulatory submissions and digital transformation.

• Develops and coordinates technical solutions (e.g., SAS macros, SAS templates, R functions, ADaM templates) to automate programming activities
• Provides technical guidance and collaborates with IT, QA, System and external vendors to maintain a robust statistical computing environment
• Creates and implements software development plans with requirements, specifications, design, and test artifacts
• Develops tools to improve quality control, traceability, and documentation for biometric practices
• Identifies innovation, automation, and continuous process improvement opportunities with user communities and collaborators
• Acts as a departmental lead in technical areas and coaches programmers for capability growth
• Collaborates across Global Biometry to align strategy, processes, standards, and innovations
• Keeps up-to-date with industry trends and technologies for effective adoption in current and future needs
• Evaluates third-party software for potential integration and builds libraries and automation tools to support global standards
• Demonstrates SAS programming (SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH) and regulatory knowledge (FDA, ICH, CDISC, SDTM/ADaM).
• Defines and drives the global technical strategy for programming automation, standardization and advanced analytics
• Leads exploration of emerging technologies, cloud platforms, and modern programming frameworks to improve efficiency and scalability
• Ensures regulatory compliance and internal quality standards across technical solutions
• Gains NDA/NDAs experience and understanding of clinical data, dictionaries, and trial processes

• Experience in statistical programming and software development/testing in pharmaceutical/clinical trial environments
• Design and implementation of programming tools supporting trial analysis and regulatory submissions
• Strong understanding of clinical trial processes and regulatory requirements related to statistical programming
• Extensive experience leading technical initiatives or platforms within global programming/biometry
• Experience implementing automation frameworks or standards across clinical programs
• Advanced degree preferred; equivalent work experience considered

• Innovative thinking
• Adaptability
• Stakeholder influence and collaboration
• SAS programming language (SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH)
• R, Java, C++, Python (preferred)
• ADaM/SDTM regulatory standards