Director Biostatistics Medical Affairs

Full Time On-Site/Hybrid Biostatistics Director Biostatistics Apply for this Job 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.

For the expansion of our team, argenx is looking for a Director Biostatistics Medical Affairs. The incumbent is Operating as a strategic thought leader in the Biostatistics Department and provides technical leadership and operational support for the design, implementation and interpretation of post-approval clinical trials, programs and disease registries.

The candidate will provide statistical support and guidance on premarket approval registry/observational studies, post-market clinical and Real World Evidence (RWE), HEOR, and epidemiological studies. This position will partner with key internal and external stakeholders and support all statistical and methodological activities in designing, analyzing, interpreting, and publishing post-market clinical studies in support of argenx’ product development, commercialization, post-launch activities, and payer reimbursement.

The incumbent may interact with regulatory agencies on matters related to the data for clinical programs and/or trials.

Desired Skills and Experience:

• Displays excellent communication skills with demonstrated leadership ability
• Functional management experience
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• PhD or master in Biostatistics or equivalent
• Minimum of 8 years of biostatistical experience in drug development including supporting medical affairs activities.
• Experience in managing CROs and vendors is a plus
• Biotech experience is a plus