Note-Candidate Must be based in Boston, MA or surrounding area
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