Biostatistical Director

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

Responsibilities include:

· 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.