Lead Statistical Programming Architect - Macro, Automation & AI

Experteer Overview In this role you will steer the long-term programming technology strategy within Global Biometry, driving automation and digital transformation across therapeutic areas. You will lead cross-functional programming teams, shape scalable solutions, and ensure regulatory-aligned, efficient data analysis and reporting. You’ll partner with IT, Data Management, Biostatistics, and external vendors to implement robust, compliant platforms. This is a hands-on, strategic role at the intersection of statistics, programming, and innovation that impacts clinical data analysis and regulatory submissions. Compensation / Benefits * Develop and coordinate technical solutions (SAS macros, SAS templates, R functions/packages, ADaM templates) to automate programming activities * Provide technical guidance and collaborate with IT, QA, System, and external vendors to maintain a robust statistical computing environment * Create software development plans including requirements, design, and test plans * Build tools to improve quality control, traceability, and documentation * Identify innovation and process improvement opportunities with user communities and collaborators * Act as departmental lead in technical areas, coaching programmers for capability development * Engage with cross-functional groups to align strategy, standards and innovations across therapeutic areas * Keep up-to-date with industry processes, trends, and technologies to support current and future needs * Evaluate third-party software for potential integration into the overall solution * Develop and maintain libraries, repositories, and automation tools to support global standards Tasks * Experience in statistical programming and software development in pharma/clinical trials * Designing and implementing programming tools for clinical trial analysis and regulatory submissions * Strong understanding of clinical trial processes and regulatory requirements for statistical programming * Extensive experience leading technical initiatives within global programming or biometry * Proven track record implementing automation frameworks or standards across multiple programs * Demonstrated experience with cloud-based platforms and developing tools (preferred) * Proficiency in SAS programming (SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH) and statistics * Knowledge of regulatory guidelines (FDA, ICH), CDISC, SDTM/ADaM * Experience organizing NDA/nda regulatory submissions * Experience with clinical data and medical dictionaries * Software design experience with R, Java, C++, JavaScript, Python (highly preferred) * Bachelor’s degree in computer science, mathematics, data science/analytics, public health or related field * Advanced degree (Master or PhD) preferred Key requirements *

test plans * Build tools to improve quality control, traceability, and documentation * Identify innovation and process improvement opportunities with user communities and collaborators * Act as departmental lead in technical areas, coaching programmers for capability development * Engage with cross-functional groups to align strategy, standards and innovations across therapeutic areas * Keep up-to-date with industry processes, trends, and technologies to support current and future needs * Evaluate third-party software for potential integration into the overall solution * Develop and maintain libraries, repositories, and automation tools to support global standards Tasks * Experience in statistical programming and software development in pharma/clinical trials * Designing and implementing programming tools for clinical trial analysis and regulatory submissions * Strong understanding of clinical trial processes and regulatory requirements for statistical programming * Extensive experience leading technical initiatives within global programming or biometry * Proven track record implementing automation frameworks or standards across multiple programs * Demonstrated experience with cloud-based platforms and developing tools (preferred) * Proficiency in SAS programming (SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH) and statistics * Knowledge of regulatory guidelines (FDA, ICH), CDISC, SDTM/ADaM * Experience organizing NDA/nda regulatory submissions * Experience with clinical data and medical dictionaries * Software design experience with R, Java, C++, JavaScript, Python (highly preferred) * Bachelor’s degree in computer science, mathematics, data science/analytics, public health or related field * Advanced degree (Master or PhD) preferred Key requirements *