Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Role:
- Statistical leader in the cross-functional development team of one compound/indication
- 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
- 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
- Report to a disease area team leader, within the Biostatistics and Statistical Modelling organisation
- Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
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Desired Skills, Qualifications and Experience:
- 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)
- 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
- Experience in clinical trial design and scenario-planning
- Extensive experience in the Pharma or Biotech environment
- Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials
- Expertise in Bayesian statistics
- Proficient in statistical software (SAS and/or R);
- Able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
- Clearly explain complex statistical concepts in written and spoken English and not afraid to contribute and speak up when necessary
- Team-player with focused attitude
- 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:
- Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies
- A work-environment in a human-sized, dynamic, rapidly growing biotech company
- 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.