[Remote] Clinical Application Specialist I – Epidemiology

Note: The job is a remote job and is open to candidates in USA. Spark Life Solutions Inc is seeking a Clinical Application Specialist I to support the Global Epidemiology team within Clinical Sciences. The role supports epidemiological study design and execution, real-world data analysis, safety evaluations, and regulatory submissions for pharmaceutical products and medical devices.

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

Skills

• 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
• 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

Benefits

• Remote (USA)

Company Overview

Company H1B Sponsorship