Clinical Application Specialist
 Spectraforce Technologies | |
 United States, California, South San Francisco | |
 Feb 27, 2025 | |
|
Job Title: Clinical Application Specialist
Location: 100% Remote Length of Contract:12 months 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: * Demonstrated experience in managing large studies or projects * Understanding of epidemiology methods and study design * Knowledge of public and private databases including large observational databases * Excellent oral and written communication skills * Strong organizational skills and ability to meet deadlines * Ability to generate tables, listings, and graphs for compound projects. Responsible for the validation and quality assurance of any output produced. * Prefer candidate with industry experience * Prefer candidate with experience in SAS, R, Aetion, or other data analytic platform Required Experience: * MPH or MS with more than 3 years of experience or PhD/MD/PharmD with experience in the field of epidemiology, outcomes research, or related discipline. Preference given to individuals with industry experience. * Excellent understanding of epidemiologic data sources, methods, and study design; and a demonstrated ability to apply them to address program needs * Knowledge of public and private real-world data sources including large observational databases * Experience with disease state epidemiology (eg, population sizing) globally and regionally using short-term studies/analyses * Demonstrated experience in managing large studies or projects * Excellent oral and written communication skills * Strong organizational skills and ability to meet deadlines 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. | |