Director, Epidemiology RWE – Immunology, Oncology

This is a fully remote position, open to applicants in California.

📋 Description

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

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

• Lead the planning, design, and execution of analyses for both internal and external decision-making (e.g., responses to regulatory authorities, prompt analyses of safety queries).

• Spearhead the identification of suitable data for the timely implementation of the RWE strategy.

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

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

• Assist in effectively communicating study/analysis results to facilitate internal and external decision-making.

• Coauthor abstracts and manuscripts for the external sharing of methodological study outcomes.

• Aid in the development of processes and training focused on enhancing the efficiency, quality, and impact of functional operations.

• Technical Expertise: Proficient in observational research methods (both Primary and Secondary), possessing a thorough knowledge of biostatistics and analysis techniques, as well as an understanding of regulatory processes.

• Capable of independently designing studies, translating research questions into appropriate study designs.

⛳️ Requirements

• PhD in Epidemiology, Biostatistics, Psychometrics, or a related discipline with at least four (4) years of relevant post-doctoral experience, preferably within the pharmaceutical industry, biotechnology, or consulting sectors.

• Profound understanding of observational research methodologies and experience in supporting the design and execution 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 proven record of scientific publications reflecting expertise in observational study design, analysis, and interpretation is preferred.

• Demonstrated capacity to operate with increasing autonomy and cultivate productive cross-functional collaborations in a matrix environment.

• Ability to prioritize tasks and meet performance objectives.

• Preferred experience in leading drug development projects for over 2 years in the therapeutic area of assignment.

🏝️ Benefits

• Company car or car allowance.

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

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