Principal Biostatistician(Job Number: 1204585)
The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.
•Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
•Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
•Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
•Translates scientific questions into statistical terms and statistical concepts into layman terms
•Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master’s degree with relevant experience required.
•Understanding of the application of biostatistics to medical/clinical trials data.
•Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
•Excellent verbal and written communications skills.
•Ability to be flexible and adapt quickly to the changing needs of the organization.
•Ability to organize multiple work assignments and establish priorities.
•Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
Job Function: Biostatistician
Primary Location: NA-US-CT-Wallingford
: R&D - Global Development Medical Affairs (GDMA)
- 3 years ago - save job
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