What are the responsibilities and job description for the Clinical Application Specialist II/Epidemiologist position at US Tech Solutions, Inc.?
Job Description
Job Description
The person in this contractor position will provide support to the Global Epidemiology department in Clinical Sciences. This person will contribute to the design and execution of pharmacoepidemiologic studies, support characterization of descriptive epidemiology for diseases and indications, contribute to regulatory submissions and responses, and perform literature reviews on topics required for ongoing support and / or development of drugs and devices.
Responsibilities :
- Evaluate, synthesize, and communicate epidemiology literature in both written and presentation formats
- Lead or contribute to the development of new evidence through study design , protocol development, and statistical analysis plans of various databases, including secondary data sources, such as administrative claims or health records data
- Support departmental need to contribute to and develop content for sections of risk management plans, benefit risk assessments, safety and regulatory deliverables
- Understand the role of epidemiology in signal evaluation and where epidemiology contributes to key safety and regulatory deliverables
Required Skills :
Required Experience :
Top 3-5 skills, experience or education required
1. Educational Background : PhD in epidemiology, outcomes research, or a related discipline preferred.
2. Technical Expertise in Data Synthesis : Experience in conducting comprehensive literature reviews to synthesize current research findings and identify gaps in existing knowledge. This includes proficiency in using databases such as PubMed, Embase, and Cochrane Library , as well as expertise in assessing the quality and relevance of scientific articles.
3. Technical Expertise in RWD : Demonstrated understanding of research methodology in real-world evidence generation , including data sources, study design, and interpretation
4. Regulatory Knowledge : Understanding of methods for adverse event collection and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management processes. Knowledgeable of U.S. and international safety regulations and current regulatory safety review processes.
5. Communication Skills : Ability to clearly communicate epidemiology concepts, both verbally and in writing, to diverse audiences. Able to articulate study rationale, design, and expected impact on supported programs.
About US Tech Solutions :
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
