Summary & Purpose Of The Position

The Lead Statistical Programming Architect – Macro, Automation & AI role is responsible for making decisions and recommendations that impact efficiency, timeliness, and quality of deliverables from biometry. This role will provide leadership, direction, and technical and project-specific guidance to programming teams across therapeutic areas such as Oncology, Rare Disease, and Neurosciences.

The role acts as a strategic technical leader responsible for shaping the long-term vision of programming technologies, driving digital transformation within biometry, and influencing cross-functional data and analytics strategies across R&D.

The role partners closely with Data Management, Biostatistics, Clinical Development, IT, and external vendors to ensure that technical solutions support regulatory compliance, operational efficiency, and innovation in clinical data analysis and reporting.

Main Responsibilities & Technical Competencies

• Develops and/or coordinates the development of technical solutions (e.g. SAS macros, SAS template programs for datasets and TFLs, R functions/packages and tools, ADaM specification template) that support the automation of clinical and/or statistical programming activities inside global biometry, providing technical support and training as needed.
• Provides technical guidance and collaborates with IT, QA, System, and external vendors to build/maintain a robust, controlled, and productive statistical computing environment.
• Develops and implements robust software development plans including user requirement specifications, functional specifications, design specifications, and test plans and scripts as required.
• Develops and/or coordinates technical tools to enhance quality control, traceability, and good documentation practices for biometric practices.
• Collaborates with the user community and internal/external collaborators to identify innovation, automation, and continuous process improvement opportunities.
• Serves as a departmental lead in areas of technical expertise. Coaches and trains clinical and/or statistical programmers to support the continuous improvement of technical capabilities.
• Connects with cross-functional groups within global biometry to identify, influence, and tap into connections in strategy, processes, standards, and innovations across therapeutic areas.
• Maintains up-to-date industry knowledge of processes, trends, and technologies ensuring efficient implementation and adoption to support current and future needs.
• Evaluates third-party software application(s) targeted for possible integration into the overall solution, including strategic application(s), tools, and utilities.
• Develops and builds application(s) libraries, global code repositories, and automation tools to support global standards for Clinical and/or statistical programming.
• Demonstrable knowledge of SAS programming language including SAS/MACRO, SQL, and SAS/BASE procedures, SAS/GRAPH, and Statistical procedures.
• Demonstrable knowledge of regulatory requirements (FDA, ICH), such as CDISC, SDTM/ADaM IG, etc.
• Defines and drives the global technical strategy for programming automation, standardization, and advanced analytics capabilities within Global Biometry.
• Identifies and implements emerging technologies, modern programming frameworks, and cloud-based platforms to improve the efficiency, scalability, and traceability of clinical programming activities.
• Ensures all technical solutions comply with regulatory expectations and internal quality standards.
• Demonstrable experience in organizing NDA/s NDA regulatory submissions.
• Demonstrable experience of Clinical data and medical dictionaries.
• Demonstrable understanding of clinical trials - how programming deliverables fit into the process, what types of data are collected, mapped, and analysed.
• Demonstrable experience working with developing tools and supporting cloud-based platforms.
• Software design experience with other languages (e.g. R, Java, C++, JavaScript, Python, etc.) highly preferred.