Biostatistical Director - Stat Disease Leader

argenx SE; Oost-Vlaanderen; On-site; EUR 120,000 - 180,000; Full time

Job summary

argenx SE is seeking a Disease Area Lead Statistician to steer statistical strategy across Early Development, Research & Discovery and Clinical Development. You will lead a team of biostatisticians, shaping analyses, interpretation, and reporting for multiple assets and indications throughout the product lifecycle.

You will collaborate with QS and other functions, drive innovative statistical methods, manage CROs, and ensure regulatory alignment and timely deliverables in a fast-growing biotech

Qualifications

• PhD or Master’s degree in statistics or related discipline.
• Minimum of 10 years biostatistical experience in drug development.
• Demonstrated people leadership and management skills.
• Demonstrated ability to work in interdisciplinary contexts outside statistics.

Responsibilities

• Provide strategic leadership to Biostatistics function within Research & Discovery and Clinical Development, overseeing multiple assets and indications across the full argenx portfolio and through entire product lifecycle.
• Lead, mentor, and develop a high-performing team of biostatisticians, fostering innovation, scientific rigor, and cross-functional collaboration.
• Ensure high-quality statistical input across entire drug development cycle (pre-clinical and clinical development evidence generation).
• Build and manage a scalable ecosystem of internal and external partners to support flexible and timely delivery of statistical analyses, including stakeholder management of different outsourcing models.
• Drive novel, fit-for-purpose approaches in drug development and provide advanced level of statistical contribution to the clinical development of the responsible disease areas.
• Represent biostatistics in challenging regulatory meetings and participate in external scientific activities.
• Understands and aligns with relevant regulatory guidance.
• Takes responsibility for the compliance of team members and for the quality and timeliness of team deliverables.

Skills

Leadership

People management

Project management

Communication

Statistical expertise

Drug development

Biostatistics

SAS

R

CRO management

Biotech experience

Education

PhD or Master’s degree in statistics or related discipline

Tools

SAS

R

Job description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Disease Area Lead Statistician contributes to the strategic statistical direction at argenx through expert-level guidance and input to Early Development, Research & Discovery and Clinical Development. The Disease Area Lead Statistician manages direct reports as a people leader, and is a leader for strategies, processes, skills, and culture within Biostatistics and Quantitative Sciences (QS). Provides collaborative leadership and quantitative expertise to other drug development scientists. Oversees the delivery of analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs. In partnership with other QS functions, contributes to strategic long-term decision-making by argenx Senior Management. Participates in external activities to help shape the external drug research and development and regulatory environments.

Reporting Line

Head of Biostatistics & Statistical Modelling

Roles and Responsibilities

• Provide strategic leadership to Biostatistics function within Research & Discovery and Clinical Development, overseeing multiple assets and indications across the full argenx portfolio and through entire product lifecycle.
• Lead, mentor, and develop a high-performing team of biostatisticians, fostering innovation, scientific rigor, and cross-functional collaboration.
• Ensure high-quality statistical input across entire drug development cycle (pre-clinical and clinical development evidence generation).
• Build and manage a scalable ecosystem of internal and external partners to support flexible and timely delivery of statistical analyses, including stakeholder management of different outsourcing models.
• Drive novel, fit-for-purpose approaches in drug development and provide advanced level of statistical contribution to the clinical development of the responsible disease areas.
• Represent biostatistics in challenging regulatory meetings and participate in external scientific activities.
• Understands and aligns with relevant regulatory guidance.
• Takes responsibility for the compliance of team members and for the quality and timeliness of team deliverables.

Skills and Competencies

• Exhibited leadership skills and high levels of initiative, drive and commitment with an ability to adopt an entrepreneurial and innovative style.
• Strong cooperative, collaborative project management skills and able to respond rapidly to changing priorities.
• Proven ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Good communication skills and proficiency to work independently.
• Broad knowledge in multiple statistical areas, good understanding of advanced statistical concepts and excellent understanding of drug development.
• Proficient in statistical software like SAS or R.
• Experience in managing CROs and vendors is a plus.
• Biotech experience in auto-immune or GI or rare diseases or respiratory is a plus.

Education, Experience and Qualifications

• PhD or Master’s degree in statistics or related discipline.
• Minimum of 10 years of biostatistical experience in drug development.
• Demonstrated people leadership and management skills.
• Demonstrated ability to work in interdisciplinary contexts outside statistics.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences.

argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility.