Lead Statistical Programming Architect – Macro, Automation & AI

Lead Statistical Programming Architect – Macro, Automation & AI

Lead Statistical Programming Architect – Macro, Automation & AI role at Ipsen Innovation (SAS). Responsible for making decisions to improve efficiency, timeliness, and quality of biometry deliverables. Provides leadership, technical guidance, and project-specific support to programming teams across Oncology, Rare Disease, and Neuroscience, acting as a strategic technical leader shaping the long‑term vision of programming technologies and driving digital transformation within R&D.

Main Responsibilities & Technical Competencies

• Develop and coordinate technical solutions (e.g., SAS macros, SAS template programs for datasets and TFLs, R functions/packages, ADaM specification templates) that support automation of clinical and statistical programming activities globally.
• Provide technical guidance and collaborate with IT, QA, Systems, and external vendors to build and maintain a robust, controlled, and productive statistical computing environment.
• Develop and implement robust software development plans including user requirement specifications, functional specifications, design specifications, and test plans and scripts.
• Develop and coordinate technical tools to enhance quality control, traceability, and GCP documentation practices for biometric practices.
• Collaborate with the user community and internal/external collaborators to identify innovation, automation, and continuous process improvement opportunities.
• Serve as a departmental lead in areas of technical expertise, coach, and train clinical and statistical programmers to strengthen technical capabilities.
• Connect with cross‑functional groups within global biometry to identify, influence, and tap into connections in strategy, processes, standards, and innovations across therapeutic areas.
• Maintain up‑to‑date industry knowledge of processes, trends and technologies ensuring efficient implementation and adoption to support current and future needs.
• Evaluate third‑party software applications targeted for possible integration into the overall solution, including strategic applications, tools and utilities.
• Develop and build application libraries, global code repositories and automation tools to support global standards for clinical and/or statistical programming.
• Demonstrable knowledge of SAS programming (SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH, statistical procedures).
• Demonstrable knowledge of regulatory requirements (FDA, ICH) such as CDISC, SDTM/ADaM IG.
• Define and drive the global technical strategy for programming automation, standardization and advanced analytics within Global Biometry.
• Identify and implement emerging technologies, modern programming frameworks and cloud‑based platforms to improve efficiency, scalability and traceability of clinical programming activities.
• Ensure all technical solutions comply with regulatory expectations and internal quality standards.
• Demonstrable experience in organizing NDA/submissions and managing clinical data and medical dictionaries.
• Demonstrable experience working with development tools and supporting cloud‑based platforms.
• Software design experience with other languages (e.g., R, Java, C++, JavaScript, Python) highly preferred.

Behavioural Competencies Required

• Cultivate innovation: create new and better ways using latest technology advancements for the function to be successful.
• Adaptability: adjust to changes while maintaining high performance and necessary compliance.
• Drive engagement: create a climate where people are motivated to contribute to standardization and process improvement.
• Strategic mindset: translate long‑term business priorities into scalable technical solutions.
• Influence and collaboration: build strong relationships across functions and influence stakeholders without direct authority.
• Develop talent: coach and mentor programming staff to strengthen technical expertise and promote continuous improvement.
• Decision quality: make timely, well‑informed technical decisions balancing innovation, compliance and operational feasibility.

Knowledge & Experience – Essential

• Experience in statistical programming and software development/testing in a pharmaceutical/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 & Experience – Preferred

• Experience working within global matrix R&D organizations and collaborating with cross‑functional teams.
• Experience with modern analytics environments such as R‑based workflows, cloud computing environments or integrated data platforms.
• Experience contributing to industry standards development or professional working groups.

Education / Certifications – Essential

• Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth).

Education / Certifications – Preferred

• Advanced Degree (Master’s, PhD or equivalent).

Languages – Essential

• English.

Languages – Preferred

• French.

Equal Opportunity Statement

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us ». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l’inclusion et de l’égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d’aménagements ou d’aide pendant le processus de candidature, veuillez en informer l’équipe de recrutement. Ces informations seront traitées avec soin et n’auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life‑changing projects that create positive impact for patients and society.