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.
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
REPORTING LINE
Head of Statistical Modeling & Innovative Solutions
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.
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.
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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