Director, Biostatistics and Modeling

Director, Biostatistics and Modeling argenx Ghent, Belgium PURPOSE OF THE FUNCTION The Statistical Modeling and Innovative Solutions team partners with colleagues across Quantitative Sciences and other cross-capability teams to develop and apply innovative approaches to optimize study designs and clinical development plans, strengthen data-driven decisions, and support evidence and insights generation across the argenx portfolio. ROLES AND RESPONSIBILITIES Shape development strategy from early planning through registration and establish precedents for innovative designs, such as adaptive designs, external/hybrid/synthetic control, model-informed drug development, and Bayesian approaches, where they add value; Anticipate portfolio needs and set the research direction for advanced statistical methodology; Champion enterprise initiatives that turn diverse types of data into actionable insights for optimizing clinical development strategy and study design; Lead the statistical strategy for regulatory interactions on novel and complex designs, including authoring briefing materials and representing argenx in health-authority meetings; Serve as a subject-matter expert on advanced statistical methodologies, advising statisticians and cross-capability teams on study design challenges and fit-for-purpose solutions; Coach statisticians and lead knowledge sharing across the organization; Represent argenx in scientific societies, industry working groups, regulatory-industry forums and academic partnerships, help moving the field forward and bring emerging methods back into the organization. SKILLS AND COMPETENCIES Deep expertise in advanced statistical methodology, with the judgment to apply it pragmatically to development challenges; Stays at the forefront of emerging quantitative methods and technologies, with a drive to challenge the status quo; Hands-on fluency with modeling and simulation tools to develop and evaluate innovative and complex designs; Strong communication and influencing skills, with the ability to align senior cross-functional stakeholders and drive decisions EDUCATION, EXPERIENCE AND QUALIFICATIONS PhD in Statistics, Biostatistics, or related field with 8+ years of relevant pharma/biotech clinical development experience (or equivalent); Strong track record of proposing and implementing innovative trial designs, including regulatory interactions on novel designs; Demonstrated leadership of cross-capability innovation initiatives. Apply Now