Director Biostatistics

For the expansion of our team, argenx is looking for a (Associate) Director Biostatistics.
- You identify and implement innovative statistical approaches.
- You conduct or oversee modelling and simulation activities in support of the clinical trial design.
- You have acquired relevant disease expertise.
- You have a transformational role that helps shape statistical thinking in the department and beyond.
- A stretched competence is that you liaise with thought leaders in Biostatistics and have internal and external visibility regarding your expertise.
- You make decisions and recommendations that impact statistical aspects of clinical development plans of one or more compound/program.
- You have demonstrated leadership in the clinical team and towards senior management on both an operational and strategic level.
- You participate in meetings with diverse regulatory authorities (FDA, EMA, PEI).
- 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 assess potential CROs and their proposals, maintain oversight and provide strategic input on CRO collaboration.
- You have demonstrated leadership in cross-departmental operational issues.
- You are supervising biostatisticians on your project and you may have functional management responsibilities.

You will report to the Head of Biostatistics and Statistical Modelling.

**Desired Skills and Experience**:

- Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
- Fluent with other statistical software such as R, EAST, Winbugs is a plus.
- Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
- Displays excellent communication skills with demonstrated leadership ability.
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
- PhD or master in Biostatistics or equivalent
- Minimum of 6-8 years of biostatistical experience
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or oncology clinical study background is a plus

**Offer**:

- A competitive salary package with benefits;
- A work environment in a human-sized, dynamic, rapidly growing biotech company