Biostatistical Lead

argenx

5d • Remote

About The Position

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. Argenx is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs. We are looking for a (senior/principal) biostatistician, to join the team of biostatistics as part of Quantitative Sciences. The position will be located in Ghent (Belgium) or Boston (US). Working remotely is possible. Your role You will serve as the indication expert biostatistician and lead all statistical activities of a major indication (across assets) You are expected to drive novel approaches and optimize the process across all stages of clinical development in the indication you are responsible for You will drive quantitative data strategy of the indication you are responsible for and will closely collaborate with the stakeholders and lead delivery of all statistical deliverables. You will closely collaborate with program partners and stakeholders and oversee delivery of all statistical deliverables for the indication you are responsible for and contribute to HA submissions You will report to a franchise team leader, within the Biostatistics and Modeling organisation You will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements You will guide the team of statisticians supporting the different assets

Requirements

• You have a master or doctorate (Ph.D.) degree in Statistics or related field with at least 7 years of experience in biotech/pharma industry
• You have a proven record of leading statistical activities, including dossier submission and major agency interactions involving BLA/NDA/MAA (pre and post dossier submission)
• You have expertise in drug development, experience driving complex innovative designs or cutting-edge methods, with a demonstrated track record of advanced knowledge of biostatistics and a strong command of its application to clinical trials
• You are proficient in statistical software (SAS and/or R)
• You are able to collaborate with program partners and stakeholders to deliver on the statistical deliverables
• You can clearly explain complex statistical concepts in written and spoken English
• You are a team player with a focused attitude
• You are able to work autonomously as part of a cross-disciplinary team in a dynamic environment of a fast-growing biotech company with challenging timelines
• You can motivate and empower statisticians supporting you.

Responsibilities

• Serve as the indication expert biostatistician and lead all statistical activities of a major indication (across assets)
• Drive novel approaches and optimize the process across all stages of clinical development in the indication you are responsible for
• Drive quantitative data strategy of the indication you are responsible for and will closely collaborate with the stakeholders and lead delivery of all statistical deliverables
• Closely collaborate with program partners and stakeholders and oversee delivery of all statistical deliverables for the indication you are responsible for and contribute to HA submissions
• Report to a franchise team leader, within the Biostatistics and Modeling organisation
• Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
• Guide the team of statisticians supporting the different assets

Benefits

• Next to a competitive salary with extensive benefits, we offer you the chance to grow and be a part of a team driven by creativity, innovation and science.
• This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree