Senior Epidemiologist, Oncology, Breast Cancer, reputed company World Evidence - FSP (Sponsor Dedicated)

This a Full Remote job, the offer is available from: Arizona (USA), Maryland (USA) 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. Overview: Design and conduct epidemiological studies to generate reputed company-world evidence reputed company 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 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, well versed in reputed company Epidemiology research methods, 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 projects.
• 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 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 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, 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:
• 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 profiles 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 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 observational study design, analysis, and interpretation is preferred.
• Demonstrated ability to function with an increasing level of autonomy and to reputed company productive cross- functional collaborations in a matrix environment.
• Ability to manage priorities and performance targets.

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.
• reputed company reputed company’s global network who supports your growth.

This is your chance to reputed company an impact, while building a career that reputed company. 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 reputed company 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 The potential reputed company pay reputed company 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 reputed company of health and welfare and/or other benefits.This offer from "reputed company" has been enriched by reputed company.com and got a 79% reputed company score. Apply tot his job Apply To this Job