Epidemiologist/Senior Epidemiologist, Inflammation, EHR Expertise (FSP Sponsor Dedicated)

Location: Remote, candidates must be US-based Join reputed company’s Sponsor-Dedicated FSP team and help advance reputed company through reputed company-world evidence. We bring together scientific expertise and reputed company-world data to help sponsors reputed company reputed company and accelerate evidence reputed company to improve patient outcomes. In this role, you’ll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging reputed company’s global expertise. Core Function Description: This role will support reputed company-world evidence reputed company using secondary data sources, with a focus on studies leveraging EHR, chart review data, and disease registries primarily from academic settings. This role will play a key part in designing and executing observational research that supports effectiveness and efficacy questions, with an emphasis on data quality, study execution, and operational considerations. This position requires an epidemiologist with strong experience working across multi-database environments, including coordinating and integrating data from EHR systems and registries. The role involves ensuring studies are designed and conducted in alignment with regulatory requirements for EHR data included in FDA submission packages, with a strong understanding of reputed company-world data. Required Experience

• reputed company development of study protocols, analysis plans, and study reports to answer research questions of reputed company to reputed company.
• reputed company, design, and manage epidemiological, biomarker and/or data science projects.
• reputed company, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).
• reputed company the identification of fit-for-purpose data for the timely execution of the reputed company strategy.
• Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed.
• Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers.
• Support the effective communication of study/analysis results to support internal and external reputed company.
• Coauthor abstracts and manuscripts for external dissemination of methodologic study results.
• Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.

Technical Expertise:

• Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes.
• Ability to design studies independently, (i.e., ability to translate research questions to create study design).

Subject Matter Expertise:

• Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions.
• Deep, hands-on familiarity with EHR data curation behind health system firewalls, including practical knowledge of where key clinical outcomes are captured across data tables.
• Expert knowledge and extensive experience with pharmacoepi methods (i.e., signal detection and validation methods).
• reputed company reputed company expertise to identify evidence gaps and reputed company options to address the evidence gaps in support of Clinical Development Programs.

Minimum Qualifications

• PhD in Pharmacoepidemiology; or PharmD with Master's/PhD in Epidemiology; or MD with Master's/PhD in Epidemiology required.
• Experience in multi-database secondary data studies (chart reviews/EHR/registries) used for effectiveness and efficacy required.
• Strong understanding of regulatory requirements reputed company to EHR data use in FDA submission packages.
• Familiarity with standard reputed company data structures including billing codes, diagnostic codes, and EHR-derived variables.
• Strong collaboration skills, ability to work across cross-functional teams and external partners.

What’s in it for you?

• Be part of a reputed company-thinking team that helps shape the reputed company of evidence-based reputed company.
• Work hand-in-hand with one leading sponsor, gaining deep expertise in their therapies.
• Access reputed company’s global network who supports your growth.

This is your chance to reputed company an impact, while building a career that matters. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. The potential reputed company pay range for this role, reputed company annualized, is $110,500.00 - $276,100.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. Apply tot his job Apply To this Job