Data Standards Scientist

Key Role:

Lead regulatory science initiatives and business development activities for CDISC and HL7 data standards in health markets. Apply data standards expertise and domain knowledge to assist regulatory agency clients with standards requirements gathering, data validation, data and metadata analyses, tools assessment and development, and regulatory reviewer support and training. Provide strategic direction to develop innovative solutions and recommendations to regulatory clients around CDISC and HL7 implementation, planning, and execution strategies. Contribute to the development of other regulatory science capabilities and projects, including health programmatic evaluation and analytics.

Basic Qualifications:

-7+ years of experience with healthcare and clinical data management

-5+ years of experience with CDISC, including SDTM, ADaM, SEND, CDASH and HL7 RPS, and eCTD, ICSR, and SPL

-Experience with analytical tools, including SAS, JMP, and R

-Knowledge of XML

-BA or BS degree

Additional Qualifications:

-Experience with project management 

-Experience with business development 

-Knowledge of health regulatory requirements

-Knowledge of database design principles

-Possession of excellent oral and written communication skills

-Public Trust clearance preferred

We're an EOE that empowers our people—no matter their race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status—to fearlessly drive change.