Lead Statistical Programming Architect – Macro, Automation

Title:

Lead Statistical Programming Architect – Macro, Automation & AI

Company:

Ipsen Innovation (SAS)

About Ipsen:

Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human‑centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description

WHAT - 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 experien