Biomarker Biostatistics Lead

argenx SE; Oost-Vlaanderen; Sur place; EUR 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Competitive salary package

Extensive benefits

Mentorship opportunities

Résumé du poste

argenx SE in Oost-Vlaanderen is looking for a Biomarker Biostatistics Lead to oversee biomarker statistics across clinical development programs. You will translate clinical questions into robust analyses and support regulatory discussions on biomarker qualifications.

The ideal candidate has an advanced degree and significant experience in pharma or biotech, alongside strong proficiency in statistical programming using R. argenx offers a competitive salary package and benefits in a collaborative work environment.

Qualifications

• 8+ years of experience in pharma or biotech focused on clinical development.
• Expertise in statistical methods for clinical and biomarker data.
• Experience with regulatory biomarker strategy is a plus.

Responsabilités

• Lead biomarker biostatistics across clinical development programs.
• Act as primary statistical partner for cross-functional teams.
• Contribute to clear and consistent reporting through dashboards.

Connaissances

Statistical analysis

Biomarker data expertise

R proficiency

Clear communication

Formation

Advanced degree in Biostatistics, Statistics or related discipline

Outils

R

Python

SAS

Description du poste

Opportunity

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.

What you’ll do

You will serve as a Biomarker Biostatistics Lead supporting autoimmune clinical development programs from early to late phase, including translational and reverse‑translational activities.

Responsibilities include:

• Lead biomarker biostatistics across clinical development programs.
• Translate clinical and translational questions into well‑defined statistical objectives; design, justify, and execute robust analyses (e.g., longitudinal and repeated‑measures models, time‑to‑event analyses, multiplicity control); interpret results in the context of clinical relevance and program decision‑making.
• Act as the primary statistical partner for Clinical, Biomarker, and Translational teams on biomarker‑related topics, contributing to experimental design, biomarker sampling strategies, statistical sections of biomarker documents, and integrated analysis and interpretation of clinical and biomarker data.
• 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.

What you’ll bring

• 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 interpretation.
• Onsite presence in the Ghent office for 2 days per week.

Why argenx

argenx is a global immunology biotech where the science of co‑creation drives bold goals and real patient impact. We dare to do more—together. We pride ourselves on an inclusive environment, offering a competitive salary package and extensive benefits.

We are an equal‑opportunity employer. All applicants are welcomed in an inclusive environment and 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.