Director Biostatistics, team leader
For the expansion of our team, Argenx is looking for a Team Leader Biostatistics within the biostatistics team, part of Quantitative Sciences.
Your Role
You contribute with your statistical expertise to scientific strategy, design and analysis of of the clinical development plan of one compound/program.
You will closely collaborate with program partners and stakeholders to lead with agility the operational execution of the statistical deliverables for one or more clinical trials and HA submissions
You will lead a team of (lead) biostatistician for multiple indications in a disease area and report to the Head of Biostatistics and Statistical Modeling
You will have a transformational role to shape the statistical organisation and thinking,
You contribute and/or take ownership in the development of departmental policies and you successfully advocate the use of standards within and across programs.
You will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
You assess potential CROs and their proposals, maintain oversight and provide strategic input on CRO collaboration.
Desired Skills, Qualifications and Experience
You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 6-8 years experience in a pharma or biotech organisation
You have expertise in drug development, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
You are proficient in statistical software (SAS and/or R);
You have demonstrated leadership in the clinical team and towards senior management on both an operational and strategic level, and experience in regulatory interactions.
You can clearly explain complex statistical concepts in written and spoken English
You are a team-player with focused attitude
You are able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast growing biotech company with challenging timelines
What we offer
A work-environment in a human-sized, dynamic, rapidly growing biotech company
Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies
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.