Job Title: Clinical Application Specialist I – Epidemiology
Location: Remote (USA)Contract
Duration: 12 Months
Job Summary
We are seeking a Clinical Application Specialist I to support the Global Epidemiology team within Clinical Sciences. The ideal candidate will have experience in pharmacoepidemiology, epidemiological research, clinical data analysis, and SAS programming.
This role will support the design and execution of epidemiological studies, disease prevalence assessments, regulatory submissions, safety evaluations, and literature reviews related to pharmaceutical products and medical devices.
Key Responsibilities
- Support the design, development, and execution of pharmacoepidemiological studies.
- Conduct epidemiological literature reviews and summarize findings through technical reports and presentations.
- Develop study protocols, statistical analysis plans (SAPs), and research methodologies.
- Analyze real-world data (RWD), including administrative claims databases and electronic health records (EHR).
- Perform descriptive epidemiology studies to assess disease prevalence, incidence, and patient populations globally and regionally.
- Utilize SAS programming to analyze clinical and epidemiological datasets.
- Generate and validate clinical tables, listings, and graphs (TLGs) to support research projects.
- Contribute to risk management plans (RMPs), benefit-risk assessments, and regulatory submissions.
- Support drug safety evaluations, signal assessments, and regulatory responses.
- Ensure accuracy, consistency, and quality of statistical outputs through validation and quality assurance activities.
- Collaborate with epidemiologists, clinical scientists, statisticians, and regulatory teams.
Required Qualifications
Education:
- MPH or MS with 2+ years of relevant experience, OR
- PhD, MD, or PharmD with experience in epidemiology, outcomes research, or a related discipline.
- Strong understanding of epidemiological research methods, study designs, and data sources.
- Hands-on SAS programming experience is mandatory.
- Experience analyzing healthcare databases, including claims data, EHR, or other secondary data sources.
- Knowledge of descriptive epidemiology, disease prevalence, incidence, and population estimation.
- Experience generating and validating tables, listings, and graphs (TLGs).
- Strong analytical, technical writing, and communication skills.
- Ability to interpret scientific literature and communicate research findings effectively.
Preferred Qualifications
- Previous experience in the pharmaceutical, biotechnology, or clinical research industry.
- Experience in pharmacoepidemiology, real-world evidence (RWE), or outcomes research.
- Familiarity with drug safety, pharmacovigilance, and regulatory submissions.
- Experience supporting clinical studies and statistical analysis.
- Knowledge of benefit-risk assessments and risk management plans.