Your future at FDA’s Center for Biologics Evaluation & Research (CBER) begins here…
FDA IS HIRING: HEALTH SCIENTIST (Digital Health Specialist)
The FDA Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), Analytics and Benefit-Risk Assessment (ABRA) Staff, Digital Health Technologies Review Team (DHTRT) is offering an opportunity for a Health Scientist with a digital health specialization.
CBER is responsible for regulation of biologic products including vaccines; allergenics; blood components and blood-derived products; tissues; and cell, gene and advanced therapeutics.
As a member of the Digital Health Technology Review Team, the candidate will work with OBPV, other CBER offices, and across the centers to conduct DHTs-related reviews and activities. These activities include but are not limited to, development of DHTs guidance, training material, familiarizing and training other FDA staff, and participating in public and industry meetings on DHTs-related topics and discussions.
MAJOR DUTIES
- Conduct reviews and evaluations of DHT-related aspects of clinical trials and drug/biologics applications.
- Participate in developing and conducting trainings for FDA staff to promote and increase awareness of DHTs, their health benefits and risks, challenges.
- Engage in development of digital health policies and enhancement of CBER DHTRT internal processes to support ongoing regulatory clarity.
DESIRED KNOWLEDGE AND EXPERIENCE
- A doctoral degree in Health Informatics, Public Health, Computer Science, or a related field.
- Proficiency in modeling and advanced analytics
- Experience in one, or more of the following areas is required: DHTs-generated data, digital therapeutics, machine learning, artificial intelligence, novel digital health technology, mobile medical apps, data interoperability, big data, or cloud technology
- Strong analytical skills along with written and oral communication skills
- High level of interpersonal skills to interact and negotiate with many different stakeholders
- Applications will be accepted from all groups of qualified candidates, including U.S. Citizens. Non-U.S. Citizens holding valid immigration status and work authorization may apply for staff fellowship appointments.
INTERESTED? Send us an email (CBER-DHTRT@fda.hhs.gov) and tell us about your special attributes; be sure to attach your resume/curriculum vitae and supporting documentation will be accepted through March 10, 2023.
