Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 135 years.
In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
The Director Epidemiology Health Outcomes will initially develop and execute epidemiology and health outcome strategies with a focus on post-approval marketing and product launches. Will also develop and execute epidemiology and health
outcome strategies for pharmacovigilance and drug development throughout the lifecycle of assigned products. Must be a motivated self-starter who can work independently.
DUTIES AND 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.
- PhD in Epidemiology or related field, or MD with a Master s 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 working with CRO's is desired.
- Prior experience working on HEOR projects is a plus.
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you should apply online at: https://www.shionogi.com/careers/careers.html -- or email your resume to: Shionogi - Human Resources .
We look forward to reviewing your resume & qualifications.
- We are an Equal Opportunity Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP here.