Senior Epidemiologist, Oncology, Breast Cancer FSP; Sponsor Dedicated

Senior Epidemiologist, Oncology, Breast Cancer, Real World Evidence - FSP (Sponsor Dedicated) page is loaded## Senior Epidemiologist, Oncology, Breast Cancer, Real World Evidence - FSP (Sponsor Dedicated) locations: Durham, North Carolina, United States of America: Rockville, MD, United States of America: Phoenix, AZ, United States of America: Parsippany, New Jersey, United States of America time type: Full time posted on: Posted Todayjob requisition : R1522347

• * Senior Epidemiologist, Oncology, Breast Cancer, Real World Evidence - FSP (Sponsor Dedicated)
• * Location:

Remote, candidates must be US-based Join IQVIA’s Sponsor-Dedicated FSP team and help advance healthcare through real-world evidence. We bring together scientific expertise and real-world data to help sponsors make decisions and accelerate evidence generation to improve patient outcomes. In this role, you’ll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging IQVIA’s global expertise.

• * Overview:
• * Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies. Skill sets of the Epidemiologist role are similarly required, with the expectation of more experience, able to operate strategically under limited supervision, well versed in current Epidemiology research methods, deep understanding of how RWE fits within drug development, regulatory, medical, safety and other functions.
• * Responsibilities:
• ** Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE.
• Lead, design, and manage epidemiological, biomarker and/or data science projects.
• Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).
• Lead the identification of fit-for-purpose data for the timely execution of the RWE 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 decisions.
• 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. o 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. + Lead the design and execution of post-marketing and observational safety studies to evaluate product risk profiles and inform regulatory and clinical decision-making. + Contribute to engagements with regulatory authorities to provide scientific input, respond to safety-related inquiries, and ensure compliance with evolving regulatory requirements.
• * Requirements:**

• PhD in Epidemiology with a minimum of four (4) years of post-doctoral experience, preferably at a pharmaceutical company. Master’s degree in Epidemiology plus 7-9 years of experience in lieu of PhD may be acceptable. • Oncology Specific: expert knowledge and extensive experience (at least 2+ years leading studies) with cancer epi (solid tumor experience a plus), extensive experience with oncology EMR databases, extensive experience with conducting cancer epi studies. • ** Pharmaco Epidemiology Specific: expert knowledge and extensive experience with pharmacoepi methods (i.e., signal detection and validation methods), expert understanding of regulatory requirements for safety reporting and analysis, RMPs, and PASS both US and global.

• ** Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.
• Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases.
• A record of scientific publications demonstrating expertise in…

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