Director, Epidemiology RWE (Immunology or Oncology)
Syneos Health/ inVentiv Health Commercial LLC
Director, Epidemiology RWE (Immunology or Oncology) Job 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. Construct cohorts using RWD sources (claims, EHR) and evaluate key variables, including diagnosis and procedure 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 methodological study results. Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities. Demonstrate technical expertise in observational research methods (both primary and secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes, and ability to design studies independently, translating research questions into study designs. Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (claims, EHR, PRO/COA, registry data) for methodological research questions. Minimum Qualifications PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four years of post‑doctoral experience in the pharmaceutical industry, biotechnology, or consulting environment; or a Master’s degree with 7–9 years of experience in lieu of a PhD. Deep understanding of observational research methods and experience supporting 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 (electronic medical records and/or medical claims databases). Record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation. Demonstrated ability to function autonomously and develop cross‑functional collaborations in a matrix environment. Ability to manage priorities and performance targets. Experience leading drug development projects for 2+ years in the therapeutic area of assignment preferred. Benefits Company car or car allowance. Health benefits: medical, dental, and vision. Company match 401(k) plan. Eligibility to participate in Employee Stock Purchase Plan. Eligibility to earn commissions/bonus based on company and individual performance. Flexible paid time off (PTO) and sick time. Compliance with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC
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