Director Biostatistics

Director Biostatistics

argenx

Ghent, Belgium

The (Associate) Director Biostatistics has a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials.

  • 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.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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