Senior Epidemiologist, Oncology, Breast Cancer, Real World Evidence FSP (Sponsor Dedicated)
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Job Location:
Durham, NC - USA
Monthly Salary:
$ 110500 - 276100
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Senior Epidemiologist Oncology Breast Cancer Real World Evidence - FSP (Sponsor Dedicated)
Location: Remote candidates must be US-based
Join IQVIAs 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 this role youll work closely with one sponsor gaining deep knowledge of their therapies while leveraging IQVIAs 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. Masters 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 develop productive cross- functional collaborations in a matrix environment.
Ability to manage priorities and performance targets.
Whats in it for you
Be part of a forward-thinking team that helps shape the next generation of evidence-based healthcare.
Work hand-in-hand with one leading sponsor gaining deep expertise in their therapies.
Access IQVIAs global network who supports your growth.
This is your chance to make an impact while building a career that matters.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare 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
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $110500.00 - $276100.00. The actual base pay offered may vary based on a number of factors including job-related 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.
Required Experience:
Senior IC
Key Skills
- Hospital Experience
- Acute Care
- Basic Life Support
- ICU Experience
- Infusion Experience
- Triage
- TFS
- Conflict Management
- Nursing
- Critical Care Experience
- Epic
- Medication Administration
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
