Head of Biostatistics

argenx

Remote, Germany

Role Overview:

In this critical role, reporting to the Head of Quantitative Sciences, you will lead and develop the biostatistics and modeling engine that drives quantitative strategies across Argenx's entire R&D portfolio. You will be a strategic partner, fostering innovation in clinical trial design and analysis while ensuring operational excellence throughout the development lifecycle. Additionally, you will serve as a backup to the Head of Quantitative Sciences, providing support and expertise as needed.

Roles and Responsibilities:

Leading quantitative strategies and developing a high-performing team of biostatisticians and modelers. You will drive design and decision making, provide strategic direction, mentorship, and foster a collaborative and innovative environment;
Partnering with cross-functional R&D teams (Asset Leaders, Clinical Development, Medical Affairs,) to design and execute high quality clinical trials and analysis across all phases (preclinical, discovery, CMC statistics, clinical development (early and late), as well as postmarketing, medical affairs);
Driving innovation in clinical trial design and analysis methodologies. You will leverage partnership with the experts to use of novel statistical methods and modeling approaches to optimize trial design, improve data quality, and expedite development timelines;
Ensuring operational excellence and efficiency across all biostatistics and modeling activities. You will establish and maintain best practices, manage workflows, and ensure adherence to regulatory requirements;
Successfully managing the ecosystem of external partners (CROs, consultants) to ensure efficient and cost-effective delivery of biostatistics and modeling services;
Scaling the biostatistics and modeling group to support Argenx's ambitious growth plans outlined in VISION 2030;
Providing expert statistical guidance to ensure the quality and integrity of clinical trial data and analyses. You will translate complex statistical concepts into clear and concise language for both scientific and non-scientific audiences;
Collaborate with regulatory authorities to address statistical questions and concerns, ensuring compliance with regulatory guidelines and requirements;
Demonstrating strong leadership skills by fostering a culture of collaboration, excellence, and continuous learning within the team;
Embracing a pragmatic and results-oriented approach that is focused on delivering medicines to patients;
Fostering a culture of talent development and mentorship within the team;
Being a cultural fit with Argenx's values of innovation, collaboration, and patient focus;
Serve as a backup to the Head of Quantitative Sciences, providing support and expertise as needed.

Education, Experience and Qualifications:

Master's or Ph.D. in Statistics, Biostatistics, or a related field;
Minimum 15+ years of experience in the pharmaceutical/biotechnology industry, with a strong track record in leading biostatistics and modeling activities for clinical development programs;
Proven experience in designing and analyzing clinical trials across all phases (preclinical to postmarketing);
Demonstrated expertise in leading quantitative science efforts for successful global regulatory submissions, including the US and Japan. This should include the development of robust statistical analyses and the effective communication of complex statistical concepts to regulatory authorities;
Demonstrated expertise in a variety of statistical methodologies, including survival analysis, longitudinal modeling, and mixed-effects models;
Demonstrated experience in applying advanced statistical methods and modeling techniques to address complex challenges in clinical development, such as designing adaptive clinical trials and/or developing innovative statistical models for complex endpoints;
Experience with pharmacokinetics (PK) and pharmacodynamics (PD), modeling is a plus. Experience in RWE data analysis is a plus;
A strong understanding of Good Clinical Practice (GCP) and regulatory requirements for clinical trials;
Excellent written and verbal communication skills, with the ability to effectively communicate complex statistical concepts to both scientific and non-scientific audiences;
Proven leadership skills, with the ability to motivate, mentor, and develop a high-performing team;
Proven commitment to quality, compliance, and inspection standards within the biostatistics and modeling function, including the implementation of robust quality management systems and the effective oversight of regulatory inspections;
A collaborative and team-oriented approach, with the ability to work effectively and autonomously in a fast-paced, dynamic environment;
A strong sense of urgency and a commitment to delivering high-quality work on time and within budget;
Cultural fit with Argenx's values of innovation, collaboration, and patient focus;
Ability to travel up to 25% of time as needed (domestic and global) with the ability to spend some time in the Boston and Gent offices.