Director, Epidemiology RWE – Onco or Immunology

This is a fully remote position, open to applicants in Connecticut, +4 more states.

📋 Description

• Oversee the creation of study protocols, analysis plans, and study reports to address research questions that are significant to RWE.

• Direct, design, and manage epidemiological, biomarker, and/or data science initiatives.

• Lead the planning, designing, and execution of analyses for both internal and external decision-making, including responses to regulatory bodies and rapid assessments of safety inquiries.

• Spearhead the identification of appropriate data for the prompt execution of the RWE strategy.

• Construct cohorts utilizing RWD sources (such as claims and EHR) and assess key variables, including diagnosis and procedure codes, along with planning validation studies as necessary.

• Contribute to the dissemination of observational research findings and methodologies, including the preparation of relevant sections of regulatory documents, reports, publications, and white papers.

• Facilitate the effective communication of study and analysis results to aid both internal and external decisions.

• Collaborate on abstracts and manuscripts for the external sharing of methodological study findings.

• Play a role in developing processes and training focused on enhancing the efficiency, quality, and impact of functional activities.

⛳️ Requirements

• PhD in Epidemiology, Biostatistics, Psychometrics, or a related field with at least four (4) years of pertinent post-doctoral experience, ideally in the pharmaceutical industry, biotechnology, or consulting environment.

• Profound understanding of observational research methods and experience in supporting the design and implementation of observational studies, including protocol, statistical analysis plan, and study report development.

• Extensive familiarity with secondary data sources and experience in secondary data analysis, encompassing electronic medical records and/or medical claims databases.

• A history of scientific publications that showcase expertise in observational study design, analysis, and interpretation is preferred.

• Proven ability to operate with increasing autonomy and cultivate effective cross-functional collaborations within a matrix environment.

• Capability to manage priorities and meet performance targets.

• Experience leading drug development projects for over 2 years in the relevant therapeutic area is preferred.

🏝️ Benefits

• Comprehensive health benefits including Medical, Dental, and Vision.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions or bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.