Regulatory Epidemiology Analyst

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. Additional program information may be found at: 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. The salary range for this position is $93,600-$104,000.00 This position is for a limited term of up to two years with the potential to convert to a full time position depending on budget availability.

ESSENTIAL FUNCTIONS

Database Architecture and Data Management 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 Epidemiologic Surveillance and Analysis 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

TECHNICAL SKILLS

Experience with the following: Relational database design and management Cloud-based computing Microsoft Access and SQL R and/or SAS ArcGIS Pro Data visualization (Tableau, Power BI, R Shiny, or similar) Data quality assurance and validation Version control

JOB QUALIFICATIONS

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

EDUCATION/EXPERIENCE REQUIREMENTS

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 Prior experience in infectious disease epidemiology and/or maternal and child health activities highly desirable Strong written and verbal communication skills Ability to multi-task and work independently Experience with regulatory and compliance adherence also preferred

PHYSICAL DEMANDS

Stand Occasionally Walk Occasionally Sit Frequently-Constantly Handling / Fingering Frequently-Constantly Reach Outward Occasionally Reach Above Shoulder Occasionally Climb, Crawl, Kneel, Bend Occasionally Lift/Carry Occasionally - Up to 40 lbs Push/Pull Occasionally - Up to 40 lbs See Constantly Speak Constantly Taste/ Smell Not Applicable Not Applicable: Not required for essential functions; Occasionally: (0 - 2 hrs/day) Frequently: (2 - 5 hrs/day); Constantly: (5+ hrs/day)

WORK ENVIRONMENT:

General Office Setting, Indoors, Temperature-Controlled. The IBTPP is located at the CDPH Richmond Laboratory Campus on Marina Bay Parkway, Richmond, CA

ADDITIONAL INFORMATION:

This position may require travel within the state of California in order to confer with CDPH staff, vendors, or regulatory contractors. When necessary, the incumbent must be able and willing to travel.

EEOC STATEMENT

It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants, without regard to age (40 and over), national origin or ancestry, race, color, religion, sex, gender, sexual orientation, pregnancy or perceived pregnancy, reproductive health decision making, physical or mental disability, medical condition (including cancer or a record or history of cancer), AIDS or HIV, genetic information or characteristics, veteran status or military service. Qualifications Skills Behaviors : Motivations : Education Experience Licenses & Certifications Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr Heluna Health