Director, Epidemiology RWE; Onco or Immunology

Director, Epidemiology RWE (Onco or Immunology)

Syneos Health is a leading fully-integrated life sciences services organization.

• 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 (e.g., claims, EHR), evaluate key variables (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, and white papers.
• Support the effective communication of study/analysis results to support internal and external decisions.
• Co-author 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.
• Technical expertise:
  • Observational research methods (both primary and secondary), deep knowledge of biostatistics and analysis methods, and understanding of regulatory processes.
  • Ability to design studies independently, translating research questions into study designs.
• Subject matter expertise:
  • Provide expertise and conduct analyses for descriptive and comparative research using RWD (e.g., claims, EHR, PRO/COA, registry data) for methodological research questions.

• 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. A master's degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field, plus 7‑9 years of experience in lieu of a 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 increasing levels of autonomy and to develop productive 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 is preferred.

We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include a company car or car allowance; health benefits (medical, dental, and vision); company‑match 401(k); eligibility to participate in an Employee Stock Purchase Plan; eligibility to earn commissions/bonus based on company and individual performance; and flexible paid time off (PTO) and sick time.

Eligibility for paid sick time may vary depending on where you work;
Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

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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; qualifications of incumbents may differ from those listed. The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above.

Nothing contained herein shall be construed to create an employment contract. All language herein complies with applicable laws of each country where the Company operates, including the EU Equality Directive, and it includes compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.