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Opportunity: Senior Manager, Epidemiology (#1003912) @ Bristol-Myers Squibb--New Haven, CT (US)
Submitted by Jody Aikawa; posted on Monday, December 06, 2010
RESPONSIBILITIES
With minimal supervision, candidate will be the lead epidemiologist for one or more development or lifecycle drugs. Author epidemiology reports for submission to health authorities, and as manuscripts for publication. Develop and execute pharmacoepidemiology plans as the lead epidemiologist. Design, execute and manage epidemiology studies conducted internally or externally by contracted research organization. Manage external investigators conducting studies for BMS. Communicate pharmacoepidemiology principles to others in R&D. Lead presentations to senior medical review boards.
Employ pharmacoepidemiologic solutions towards improving the quality and speed of GPV&E submissions to support health care providers, regulatory requests, and the public health of patients using BMS products. Provide a pharmacoepidemiologic perspective into department standards, and supports process improvement initiatives. Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals. Promoting of collegiality and teamwork among peers. Take responsibility for professional development of self and collaboration with others.
REQUIREMENTS
- Education preferred: MD or PhD and/or MPH in Epidemiology
- While the specific experience requirement will depend on the demonstrated achievements of the individual, 2-3+ years in the field of epidemiology, 2-3+ years of pharmaceutical industry experience and 1-3 years of safety epidemiology experience preferred
- Major Skills - Basic knowledge of at least one clinical therapeutic area
- Solid knowledge of pharmacoepidemiology methods and statistical methods for observational studies
- Familiarity with data resources for pharmacoepidemiology studies
- Knowledge of epidemiologic methods used in the quantification of potential safety signals, and the determination of cause and effect relationships for such signals
- Demonstrated ability to execute pharmacoepidemiology studies within the pharmaceutical industry environment
- Demonstrated experience working within a matrix environment, in particular working within safety teams, with clinical and marketing teams
- Ability to lead multiple projects supporting different compounds in the same therapeutic area
- Strong execution skills, knowledge of planning processes and implementation
- Excellent communication skills, both written and oral
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