Director, Epidemiology RWE (Immunology or Oncology)

Syneos Health Careers$120K — $150K *
US-AnywhereRemote in California, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • PhD in Epidemiology, Biostatistics, Psychometrics, or related field with 4+ years of relevant experience; Master's degree with 7-9 years may be acceptable.
  • Deep knowledge of observational research methods with experience in observational research design and reporting.
  • Extensive experience with secondary data analysis, including electronic medical records and claims databases.
  • Demonstrated track record of scientific publications in observational study design and analysis.
  • Proven ability to work autonomously and develop cross-functional collaborations.
  • 2+ years of experience leading drug development projects in relevant therapeutic area preferred.

Responsibilities

  • Lead the development of study protocols and analysis plans for RWE research questions.
  • Design and manage epidemiological and data science projects efficiently.
  • Conduct internal and external analyses to support regulatory responses and safety queries.
  • Identify and utilize appropriate data sets for effective RWE strategy execution.
  • Construct cohorts from RWD sources and evaluate relevant variables for validity.
  • Communicate research results through regulatory documents, reports, and publications.
  • Develop training and processes to enhance functional efficiencies.

Benefits

  • Company car or car allowance
  • Health benefits including medical, dental, and vision
  • 401k plan with company matching
  • Employee Stock Purchase Plan participation
  • Eligibility for performance-based commissions or bonuses
  • Flexible Paid Time Off (PTO) and sick leave options.
Full Job Description
Director, Epidemiology RWE (Immunology or Oncology)

Job Responsibilities

Oncology or Immunology

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
• 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
o 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 Expertise
o 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

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. 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 to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, 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.

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. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

About Syneos Health Careers

Syneos Health Careers

Joining Syneos Health presents an unparalleled opportunity to become part of a global team of professionals dedicated to biopharmaceutical solutions. At Syneos Health, job opportunities abound, offering a gateway to enhancing career paths in a company celebrated for its commitment to therapeutic and operational excellence.

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