Director, Epidemiology RWE (Immunology or Oncology

Position: Director, Epidemiology RWE (Immunology or Oncology)
Location: California

Director, Epidemiology RWE (Immunology or Oncology)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities Oncology or Immunology Required Experience Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWELead, 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 Expertiseo Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes,o Ability to design studies independently, (ie ability to translate research questions to create study design)
Subject Matter Expertiseo 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 databasesA 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

Abilit…