What are the responsibilities and job description for the Principal Statistician position at Maxis Clinical Sciences?
Summarized Purpose:
Principal Statistician - Staff Scientist, Biostatistics Projects
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
Desired Skills, Qualifications and Experience:
Master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 6 years of experience with a Ph. D or minimum of 8 years of experience with a master's degree (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
Expertise in Bayesian statistics
Experience in clinical trial design and scenario-planning
Extensive experience in the Pharma or Biotech Company (Not in a CRO)
Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials
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 in collaborating in a team atmosphere
Able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast-growing biotech company with challenging timelines
Other:
Must be based in Boston, MA or Greater Boston area due to client need. (In office would be on average once a month.) Not looking for resource to travel in when needed for different City or state based on Travel policy for this client.