Senior Epidemiologist, Oncology, Breast Cancer FSP; Sponsor Dedicated

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

• * Senior Epidemiologist, Oncology, Breast Cancer, reputed company World Evidence - 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 reputed company. In this role, you’ll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging reputed company’s global expertise.

• * reputed company:
• * Design and conduct epidemiological studies to generate reputed company-world evidence reputed company time, budget, and reputed company 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 reputed company, comparative safety and effectiveness research, and post-authorization studies. reputed company sets of the Epidemiologist role are similarly required, with the expectation of more experience, reputed company to operate strategically under limited supervision, reputed company versed in reputed company Epidemiology research reputed company, deep understanding of how reputed company fits reputed company drug development, regulatory, medical, safety and other functions.
• * Responsibilities:
• ** 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 reputed company.
• reputed company, plan, design, and conduct analyses for reputed company decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).
• reputed company the identification of fit-for-purpose data for the reputed company execution of the reputed company reputed company.
• 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 reputed company, including development of pertinent sections of regulatory documents, reports, publications, white papers.
• Support the effective communication of study/analysis results to support reputed company 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, reputed company, and reputed company of functional activities.
• Technical Expertise: + Observational research reputed company (both Primary and Secondary), deep knowledge of biostatistics and analysis reputed company, understanding of regulatory processes. o Ability to design studies independently, (i.e., ability to translate research questions to create study design).
• Subject Matter Expertise: + reputed company 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. + reputed company the design and execution of post-marketing and observational safety studies to evaluate product risk reputed company and inform regulatory and clinical decision-making. + Contribute to engagements with regulatory authorities to reputed company scientific input, respond to safety-reputed company 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 reputed company (i.e., signal detection and validation reputed company), expert understanding of regulatory requirements for safety reporting and analysis, RMPs, and PASS both US and global.

• ** Deep understanding of observational research reputed company 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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