Biomarker Biostatistics Lead

argenx; Gent; Sur place; EUR 75 000 - 100 000; Plein temps

Avantages offerts par ce poste

Competitive salary package

Extensive benefits

Cross-disciplinary team involvement

Résumé du poste

A leading biotech company based in Belgium is seeking a Statistical Leader for Biomarker strategies in autoimmune clinical programs. The role demands expertise in R programming and biostatistics to drive decision-making through quantitative analysis. The candidate should possess 8+ years of pharma experience and be skilled in machine learning and data analysis tools. The position offers a competitive salary and requires in-office presence in Ghent two days a week.

Qualifications

• 8+ years of experience in pharma/biotech, particularly in clinical development.
• Expertise in surrogate markers and regulatory strategies utilizing biomarkers.
• Deep understanding of statistical methods for high-dimensional data.

Responsabilités

• Lead statistical analysis for autoimmune clinical programs.
• Develop quantitative strategies for exploratory research questions.
• Ensure compliance with regulatory requirements and best practices.

Connaissances

R programming

Bioconductor

Python

SAS

Machine learning

Statistical writing

Data engineering

Git

Formation

Advanced degree in Biostatistics or related field

Outils

R/Shiny

Databricks

Snowflake

Description du poste

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.

The opportunity

You will be the statistical leader for analytical Biomarker strategies, analysis for and across autoimmune clinical programs, including support for and reverse translation—spanning early and late development. You’ll advance decision‑making through rigorous quantitative methods for Forward and Reverse Translational projects, elevate standards for reproducible science across our portfolio and contribute to shape Biomarker‑driven study designs.

What You’ll Do

• Own end‑to‑end Biomarker statistics for autoimmune and immunological disorder trials. Translate program‑critical exploratory research questions into clear, testable quantitative strategies, drive implementation and evidence‑based decision‑making; design and execute robust analyses (e.g., longitudinal models, time‑to‑event, multiplicity control); interpret and report results to drive program decisions, and formulate the findings and impact of the insights to the various stakeholder audiences, in close collaboration with key stakeholders within Quantitative Sciences (QS) and beyond in Clinical, Biomarker and Translational Scientists, and Preclinical Scientists.
• Lead innovative analysis of Biomarker and multi‑omics data. Apply rigorous methods for high‑dimensional datasets (transcriptomics/proteomics/metabolomics); integrate across modalities; define robust QC/normalization strategies.
• Apply and elevate internal Data Science excellence. Set standards for reproducible data analysis workflows and package ecosystems; mentor teams in advanced R practices for bioinformatics.
• Contribute to data reusability for metadata analysis and Reverse Translation. Champion reproducible research and traceability best practices; partner with Biomarker Data Management and Programming to ensure ALCOA++ compliance and conformance for regulatory interactions, where required.
• Advance data products & visualization. Partner with Biomarker Data Teams to get Biomarker dashboards (R/Shiny, Spotfire, or similar) and tables, lists and figures produced; promote transparent reporting linked to ADaM, where deemed required.
• Champion modern compute & collaboration. Work in Git‑first workflows; leverage cloud data and analytical platforms (Posit Team for statistical analyses, Databricks for AI/ML, Snowflake for governed analytics) with fit‑for‑purpose lakehouse/warehouse patterns used widely in life sciences.
• Mentor, influence, and represent. Provide thought leadership in Biomarker analysis and data strategy, collaborate with statistics partners, and contribute to regulatory meetings as needed—consistent with senior biostatistics leadership responsibilities.

What You’ll Bring

• Advanced degree in Biostatistics, Biomedical Science, Bioengineering, or related quantitative field; 8+ pharma/biotech experience spanning clinical development.
• Expert R & Bioconductor (package ecosystem fluency; writing robust, reproducible, tested code); Python for scientific computing and machine learning; SAS proficiency is valued.
• Expertise in surrogate markers, diagnostic, prognostic, pharmacodynamic and response predictive biomarker methods is a must; experience with regulatory strategies utilizing biomarkers a plus.
• Communication: clear statistical writing, and the ability to translate complex findings for cross‑functional teams.
• Deep experience in statistical methods for Biomarker data, including feature engineering, dimensionality reduction, longitudinal modeling, survival analysis, multiplicity adjustment, and robust inference in high‑dimensional settings.
• Hands‑on experience in machine learning (classification, clustering, regularized models; ideally MLflow‑oriented workflows in the cloud), in line with modern Biomarker development.
• Working experience with CDISC standards and submission metadata.
• Data & platform skills: Git, experience with Databricks/Snowflake; familiarity with data engineering patterns for analytics readiness, notion of CI/CD, containerization.
• Dashboarding: R/Shiny, Spotfire, or equivalent.
• On site presence in the Ghent office for 2 days/week.

Offer

• Member of a cross‑disciplinary team involved in clinical development of therapeutic antibodies.
• Opportunity to contribute to the continued build‑out of the Translational Data Science team.
• Competitive salary package with extensive benefits.

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.

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