Clinical Application Specialist II

About the Role

The Clinical Application Specialist II will support Real-World Evidence (RWE) and epidemiology research within Clinical Sciences, with a strong focus on oncology epidemiology. This role will design observational studies, develop statistical analysis plans, query and analyze real-world databases, and deliver analytical findings to epidemiologists and cross-functional stakeholders.

Responsibilities

• Design and support observational epidemiology studies, including registries, in collaboration with epidemiologists and cross-functional stakeholders.
• Develop data and statistical analysis plans and independently execute analyses with minimal technical oversight.
• Query real-world databases, create study cohorts and analytical datasets, and perform hands-on statistical programming and analysis.
• Analyze claims, EHR, and other real-world data to generate tables, figures, reports, and study findings.
• Support oncology epidemiology research involving solid tumors and hematologic malignancies.
• Convert sales data into drug exposure measures and stratify exposure by demographic and clinical factors.
• Conduct comprehensive literature reviews focused on RWE methodologies, epidemiologic methods, and coding algorithms.
• Provide epidemiology analyses and findings for regulatory and safety documents, including RMPs, PSURs, and briefing books.
• Communicate analytical results and epidemiologic findings to epidemiologists and cross-functional teams.
• Contribute to abstracts, manuscripts, study protocols, and research proposals as needed.

Qualifications

• Master's degree in Epidemiology, Health Services Research, Pharmacy Administration, Biostatistics, HEOR, or related field required.
• Ph.D. in Epidemiology, Health Services Research, Pharmacy Administration, Biostatistics, HEOR, or related field preferred.
• Master's degree candidates should have 5+ years of relevant RWE/data analytics experience.
• Ph.D. candidates should have 1-2 years of relevant epidemiology or RWE experience.

Required Skills

• Real-world data (RWD/RWE) analysis using healthcare claims and EHR databases.
• Advanced SAS and SQL programming for data manipulation and epidemiologic analysis.
• Hands-on cohort construction, data querying, analytical dataset development, and statistical analysis.
• Epidemiologic study design, observational research methods, and statistical analysis planning.
• Oncology epidemiology experience involving solid tumors and/or hematologic malignancies.
• Experience analyzing oncology EHR or real-world databases, including Flatiron Data, ConcertAI, COTA, or comparable datasets.
• Experience developing and implementing coding algorithms for real-world data.
• Experience translating clinical and epidemiologic questions into analytical approaches and study designs.
• Ability to independently generate tables, figures, reports, and analytical findings from complex RWD.
• Experience collaborating with epidemiologists and cross-functional pharmaceutical research teams.

Preferred Skills

• Flatiron Data experience strongly preferred.
• Experience with Aetion for RWE study design, analytics, or modeling.
• R programming for epidemiologic or RWE analysis.
• Pharmaceutical industry experience supporting drug safety or clinical epidemiology.
• Experience contributing RWE to regulatory and pharmacovigilance deliverables.
• Python programming and machine learning applied to healthcare or real-world data.
• Experience supporting oncology drug development or safety studies.

Pay

$58-62/hr

Schedule

12-Month Contract (Potential for Extension or Conversion)