Regulatory Epidemiology Analyst
About The Position
The Infant Botulism Treatment and Prevention Program (IBTPP) is a unique public health/public service orphan drug program in the California Department of Public Health. IBTPP is the sole producer and distributor worldwide of the public service orphan drug that it created known as BabyBIG®. BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic disease of babies. The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide. Under the direction of the Research Scientist Supervisor II, the REA provides programmatic regulatory capacity by assuring that effectiveness and utilization reporting requirements of the U.S. Food and Drug Administration (FDA) are met for BabyBIG activities. In close collaboration with epidemiological staff and supervisor, REA manages IBTPP epidemiological operations relating to BabyBIG utilization and distribution and infant botulism case investigation and surveillance. This position has a high degree of external representation for this specialized program that is highly visible within and without the Department. Incumbent REA assists with maintenance and development of IBTPP databases as needed. Additionally, the incumbent will facilitate program Data Modernization and implementation of data governance in support of standardized metrics and reports for IBTPP’s critical epidemiologic and surveillance workstreams. Incumbent will use a high degree of innovation, creative thinking, cross-team collaboration and strategic planning to complete work.
Requirements
- Be able to understand and comply with federal regulations related to orphan drug BabyBIG
- Able to work independently complete assigned work in a timely manner with only occasional or minimal supervision
- Understand and comply with current Standard Operating Procedures
- Prior experience in infectious disease epidemiology
- Master of Public Health, or Master's degree in Epidemiology, Public Health, Biostatistics, Health Informatics, Data Science, or a closely related field
- 2 – 3 years of experience in public health, database architecture, data management, and statistical analyses
- Strong written and verbal communication skills
- Ability to multi-task and work independently
Nice To Haves
- Prior experience in infectious disease epidemiology and/or maternal and child health activities highly desirable
- Experience with regulatory and compliance adherence also preferred
Responsibilities
- Co-design, create, standardize, and maintain epidemiological and operational databases and associated analytical algorithms as needed to implement and improve the program's regulatory and data management responsibilities
- Lead data governance at program level to generate buy-in and build consensus on data collection, storage, reporting and metric standards reflecting key program objectives
- Work with CDPH Information Technology Services Division to develop database architecture that is consistent with CDPH’s Strategic Goals on Data Modernization and support migration towards cloud based relational database structure, workflows and data governance practices
- Build and maintain automated data validation pipelines, data cleaning workflows and quality control procedures
- Assist in training staff on standardized data management and analytic workflows
- Perform and maintain regulatory epidemiological record-keeping for all Baby BIG treated and non-treated referrals and cases according to all current Standard Operating Procedures (SOPs)
- Perform epidemiologic analysis using statistical software (R or SAS)
- Perform geospatial and spatiotemporal analysis of surveillance data (using ArcGIS Pro and SatSCAN respectively)
- Collect surveillance data on infant botulism from physicians, state and local health department employees, health department microbiologists, and parents of patients
- Develop standardized analytical methods, specific for rare disease, statistical code libraries, and documentation to improve consistency and reproducibility across projects
- Develop automated surveillance reports, dashboards and routine summary statistics
- Produce and contribute to reports and manuscripts for publication in peer-reviewed journals and review current scientific literature to maintain professional expertise and information about infant botulism and case studies
- Evaluate and analyze, recommend implement and direct change-control measures for relevant databases and procedures for the epidemiological functions of the position and support staff
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
