Location: Cambridge,MA, USA
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
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.