Biomarker Biostatistics Lead

About the role

You will serve as a B iomarker B iostatistics L ead supporting autoimmune clinical development programs from early to late phase, including translational and reverse translational activities. In this role, you will provide scientific and statistical leadership for biomarker strategies , ensuring that analyses are methodologically sound, interpretable, and aligned with clinical questions and development objectives . You will contribute to biomarker driven study designs, integrated clinical-biomarker analyses and evidence generation, and the advancement of reproducible quantitative practices across the portfolio.

Responsibilities

• Provide statistical oversight of exploratory and translational biomarker analyses , including single, complex and high dimensional datasets, ensuring appropriate QC , normalization, sensitivity analyses, and transparent reporting.
• Support biomarker utility assessment ( e.g. exploratory, pharmacodynamic, prognostic, predictive) and contribute to discussions on biomarker qualification, interpretation, and readiness for clinical or regulatory use where applicable.
• Ensure reproducibility, traceability, and data integrity of biomarker analyses in collaboration with Biomarker Data Management and Statistical Programming, aligned with ALCOA++ principles and regulatory expectations.
• Contribute to clear and consistent reporting through high quality tables, listings, figures, and well documented dashboards that support governance, clinical interpretation, and cross study learning.
• Mentor and influence , promoting sound statistical reasoning, best practices in R based analysis, and consistency in biomarker analysis approaches across programs.
• Represent biomarker biostatistics in cross functional , governance, and (as appropriate) regulatory interactions, consistent with senior biostatistics leadership responsibilities.

Requirements

• Advanced degree in Biostatistics, Statistics, or a closely related quantitative discipline ; 8+ years of experience in pharma or biotech, with a strong focus on clinical development.
• Deep expertise in statistical methods for clinical and biomarker data , including longitudinal modeling, survival analysis, multiplicity adjustment, and robust inference across diverse biomarker endpoints.
• Proven experience with diagnostic , pharmacodynamic, prognostic, predictive, and/or surrogate biomarkers , ideally within autoimmune or immunology programs; experience supporting regulatory biomarker strategy is a plus.
• High proficiency in R for statistical analysis, reporting, and reproducible workflows; familiarity with Bioconductor or other biomarker relevant packages is valued. Python and/or SAS experience is an advantage .
• Strong ability to clearly communicate statistical concepts and results to non statisticians and senior decision makers, both in writing and in discussion.
• Experience working with CDISC standards ( SDTM/ ADaM) and contributing to submission ready or inspection ready analyses.
• Experience with version controlled , collaborative analysis environments ( e.g. Git based workflows) and good documentation practices.
• Experience with data visualization or dashboarding ( e.g. R/Shiny, Spotfire, or similar) to support clinical interp

Benefits

Additional Information

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. At argenx , we're all in on our innovation mission to transform care for people living with severe autoimmune diseases. We speak the language of science, put patients first, and value high ‑ impact over hierarchy. If you ' re energized by bold ideas and collaborative problem ‑ solving - patients are waiting.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at argenx? Share your experience