Associate Director, Epidemiology
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POST DATE 8/24/2016
END DATE 10/24/2016
Florham Park, NJ
JOB DESCRIPTIONAPPLY The Associate Director, Epidemiology will be a self-starter who will take initiative to develop and execute epidemiology and health outcome strategies for drug development, pharmacovigilance and commercial purpose throughout the lifecycle of assigned products.
DUTIES AND RESPONSIBILITIES
• Propose, design, initiate, conduct, manage, report and present observational studies that either using existing healthcare database or through primary data collection.
• Perform targeted or systematic literature reviews and produce the report on the finding.
• Contribute to the development of clinical trial protocol, value dossier and forecast.
• Develop study analysis plan based on the study concept and database specification.
• Perform statistical analyses as needed with good documentation and good quality.
• Supervise the analyses performed by vendors to ensure the accuracy and efficiency of the deliverables.
• Provide epidemiologic support and input into risk management plans and Periodic Safety Update Reports and safety evaluations for assigned products.
• Author publications/makes presentations regarding disease state awareness (e.g. scientific manuscripts, abstracts, posters, internal and external presentations)
• May assist implementation of primary observational studies by tracking the project activities (for example contract, IRB, monitoring, and site communication).
• Provides necessary input into project team budget planning; may have budget oversight for specific epidemiology activities.
• Perform other responsibilities as required.
MINIMUM JOB REQUIREMENTS
• PhD in Epidemiology or related field or MD and Master’s degree in Epidemiology or related field and at least 5-year experience as an epidemiologist in the biotech/pharmaceutical industry.
• Master’s degree in Epidemiology or related field and at least 7-year experience as an epidemiologist in the biotech/pharmaceutical industry.
• Strong knowledge of epidemiological study design, including understanding of observational and epidemiological endpoints and assessments.
• Good knowledge of drug development and life cycle management.
• Ability to proactively identify opportunities and needs for epidemiological support.
• Good statistical programming skills in SAS and understanding of efficient programming with large databases.
• Knowledge of large medical records or health claims databases such as Truven Health MarketScan.
• Good written and verbal communication skills. Experience in communicating with all levels of personnel across various departments, in domestic and international environments a plus.
• Good project management skills including experience in managing multiple tasks concurrently.
• Proven team-working, leadership, follow-through, and stakeholder management skill to supports the project(s).
• Ability to work under pressure and independently.
• Experience of working with CRO.
• Experience of working on HEOR project is a plus.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html -- and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.