868#RWE Senior Epidemiologist/Senior Observational Research Scientist

 

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is searching for a RWE-Senior Epidemiologist/Senior Observational Research Scientist  to join one of our clients. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Primary responsibilities 

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.

Required Experience
• 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 18
• 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, 
   --Ability to design studies independently, (ie 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 

Minimum Qualifications
• PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. Master’s degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field, plus 7-9 years of experience in lieu of PhD may be acceptable.
• 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
• Experience in leading drug development project for 2+ years for therapeutic area of assignment preferred