Health Outcomes - Epidemiologist 7/5/2018
Florham Park, NJ
JOB DESCRIPTIONAPPLY This Epidemiologist will develop and execute health outcome strategies with a focus on post-approval marketing and product launches. Will also develop and execute strategies for pharmacovigilance and drug development throughout the lifecycle of assigned products. Must be a motivated self-starter who can work independently.
RESPONSIBILITIES Design and conduct observational studies using either existing healthcare database or through primary data collection.
Develop study analysis plan based on the study concept and database specification.
Perform statistical analyses as needed with good documentation and good quality.
Evaluate and identify suitable healthcare data and/or vendors in different countries for the projects
Supervise and evaluate the analyses performed by vendors to ensure the accuracy and efficiency of the deliverables.
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.
Provide epidemiologic support and input into risk management plans and Periodic Safety Update Reports and safety evaluations for assigned products.
Author study report or publications and makes presentations (e.g. scientific manuscripts, abstracts, posters, internal and external presentations) to support the product before and after its regulatory approval.
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.
REQUIREMENTS PhD in Epidemiology or related field, or MD with a Masters degree in Epidemiology.
Minimum of 8 years experience as an epidemiologist to include background derived from work in the biotech or pharmaceutical industry.
Strong knowledge of epidemiological study design, including understanding of observational and epidemiological endpoints and assessments.
Strong Statistical background.
Good knowledge of drug development and life cycle management.
Ability to proactively identify opportunities and needs for epidemiological support for assigned products.
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, CPRD, etc.
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 work with little or no supervision.
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.
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information.