Biostatistics Lead
argenx
Gent, Belgium
Your role:
- You are a statistical leader in the cross-functional development team of one compound/indication
- You contribute with statistical expertise to the development strategy, decision making and interpretation of the data generated through the clinical development program, embracing excellence and innovation among quantitative methods
- You will closely collaborate with program partners and stakeholders to deliver on-time the statistical deliverables for all clinical trials and/or HA submissions of one compound/indication
- You will report to a disease are team leader, within the Biostatistics and Statistical Modelling organisation
- You will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
Desired Skills, Qualifications and Experience:
- You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 6 years experience (which may include doctoral research in field of biostatistics)
- You have expertise in drug development in a regulatory environment, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
- You have experience in clinical trial design and scenario-planning
- Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials
- You are proficient in statistical software (SAS and/or R);
- You are able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
- You can clearly explain complex statistical concepts in written and spoken English and not afraid to contribute and speak up when necessary
- 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
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