Lead Statistical Programming Architect

Salary: £49,000 - 65,000 per year

Requirements:

• Experience in statistical programming and software development and testing in a pharmaceutical or clinical trial environment.
• Experience designing and implementing programming tools supporting clinical 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 or biometry organizations.
• Demonstrated experience implementing automation frameworks or standards across multiple clinical programs.
• Knowledge of global matrix R&D organizations and collaboration with cross-functional teams is preferred.
• Experience with modern analytics environments such as R-based workflows, cloud computing environments, or integrated data platforms is preferred.
• Experience contributing to industry standards development or professional working groups is preferred.
• Demonstrable knowledge of the SAS programming language, including SAS/MACRO, SQL, SAS/BASE procedures, SAS/GRAPH, and statistical procedures.
• Demonstrable knowledge of regulatory requirements such as FDA, ICH, CDISC, and SDTM/ADaM IG.
• Demonstrable experience in organizing NDA and/or sNDA regulatory submissions.
• Demonstrable experience with clinical data and medical dictionaries.
• Demonstrable understanding of clinical trials and how programming deliverables fit into the process.
• Demonstrable experience working with tools and supporting cloud-based platforms.
• Software design experience with other languages such as R, Java, C++, JavaScript, or Python is highly preferred.
• Bachelors degree or equivalent in computer science, mathematics, data science/analytics, public health, or another relevant scientific field.
• Advanced degree such as a Masters or PhD is preferred.
• English language proficiency is essential.
• French language proficiency is preferred.

Responsibilities:

• We make decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables from biometry.
• We provide leadership, direction, and technical and project-specific guidance to programming teams across therapeutic areas.
• We act as strategic technical leaders shaping the long-term vision of programming technologies and driving digital transformation within biometry.
• We partner with Data Management, Biostatistics, Clinical Development, IT, and external vendors to ensure technical solutions support regulatory compliance, operational efficiency, and innovation.
• We develop and/or coordinate technical solutions such as SAS macros, SAS template programs for datasets and TFLs, R functions/packages and tools, and ADaM specification templates to support automation of clinical and statistical programming activities.
• We provide technical support and training as needed.
• We provide technical guidance and collaborate with IT, QA, System, and external vendors to build and maintain a robust, controlled, and productive statistical computing environment.
• We develop and implement software development plans, including user requirement specifications, functional specifications, design specifications, and test plans and scripts as required.
• We develop and/or coordinate technical tools to enhance quality control, traceability, and good documentation practices.
• We collaborate with user communities and internal/external collaborators to identify innovation, automation, and continuous process improvement opportunities.
• We serve as a departmental lead in areas of technical expertise.
• We coach and train clinical and/or statistical programmers to support continuous improvement of technical capabilities.
• We connect with cross-functional groups within global biometry to identify and influence strategy, processes, standards, and innovations across therapeutic areas.
• We maintain up-to-date industry knowledge of processes, trends, and technologies to support efficient implementation and adoption.
• We evaluate third-party software applications for possible integration into the overall solution.
• We develop and build application libraries, global code repositories, and automation tools to support global standards for clinical and/or statistical programming.
• We define and drive the global technical strategy for programming automation, standardization, and advanced analytics capabilities within Global Biometry.
• We identify and implement emerging technologies, modern programming frameworks, and cloud-based platforms to improve efficiency, scalability, and traceability of clinical programming activities.
• We ensure all technical solutions comply with regulatory expectations and internal quality standards.

Technologies:

• Cloud
• Support
• Java
• JavaScript
• Matrix
• Python
• SAS
• SQL
• AI
• Architect

More:

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of development experience and global hubs in the U.S., France, and the U.K., we work across more than 40 countries to bring medicines to patients in 88 countries. We promote human-centric leadership, collaboration, excellence, and impact, and we are committed to helping every individual grow and thrive. We also foster inclusion and equal opportunities, and we support applicants who may need adjustments during the application process. This is a full-time role based in London, Paris, or Cambridge One Main.

last updated 36 week of 2026