Lead Statistical Programming Architect – Macro, Automation & AI

Ipsen; Paris; Sur place; EUR 120 000 - 190 000; Plein temps

Résumé du poste

Ipsen is seeking a Lead Statistical Programming Architect to drive macro, automation, and AI initiatives in biometry. The role leads programming teams across oncology, rare disease, and neuroscience, shaping long-term technology strategy and digital transformation within biometry.

The candidate will collaborate with Data Management, Biostatistics, Clinical Development, IT, and vendors to ensure compliant, efficient, and innovative data analysis and reporting solutions.

Qualifications

• Experience in statistical programming in pharmaceutical/clinical trial setting.
• Experience designing programming tools for regulatory submissions.
• Strong understanding of clinical trial processes and regulatory requirements.

Responsabilités

• Defines and executes technical strategy for programming automation and analytics.
• Leads cross-functional collaboration with IT, Data Management, and QA.
• Develops and implements software development plans and validation scripts.
• Evaluates third-party tools and modern programming frameworks.
• Coaches staff to improve technical capabilities and standards across projects.

Connaissances

SAS macro programming

Automation tooling

Biometry leadership

Cloud platforms

Regulatory knowledge

Formation

Bachelor in CS/Math/Statistics

Master's degree preferred

Outils

R

Python

SAS

Description du poste

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 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.

Behavioural Competencies Required

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

Knowledge & Experience

Essential:

• Experience in statistical programming and software development and 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.

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).

Preferred:

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

Language(s)

Essential:

• English

Preferred:

• French

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