Principal Statistician

Duties:

• 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 organization
• Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements

Requirements:

• 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