Note: The job is a remote job and is open to candidates in USA. BridgeBio is hiring a Principal Clinical Database Systems Programmer to design, build, and maintain clinical data collection systems. The role leads clinical programming across studies, including EDC database builds, programmed data reports and visualizations, and coordination of data specifications with study teams and biostatisticians.
Responsibilities
- Creates standard and/or custom programs/reports using data analytics tools such as SAS, Tableau, or other data visualization tools to support data oversight and review by data managers or other data reviewers
- Leads EDC database build programming, testing, and migration of CRFs and edit checks or dynamics (database specifications, etc.) using EDC platforms (e.g. Veeva Vault, Medidata Rave)
- Collaborates with clients, peers, programmers, project teams, and/or requestors to clarify and finalize data specifications; uses expanded technical skills to meet evolving project needs
- Supports the development, delivery and maintenance of clinical data review standards, tools and systems, across various data sources (e.g., clinical data, safety and operational data)
- Supports initiatives for Data Management and Clinical Programming for clinical data review bridging and database development activities, meetings, discussions
- Assists in the management of electronic data from external data sources/vendors in partnership with the Data Management Lead for import or integration to clinical database tools. Liaises with vendors as needed to facilitate electronic data transfers and/or data specification requirements
- Assists in review and approval of required study documentation, including design specifications, user requirements, data transfer specifications and data standards
- Provides leadership, training, guidance, and support to other department members on data review tools and clinical database development
Skills
- Bachelor's degree (or equivalent) in Science and/or Computer Systems/IT background
- Minimum 5-7 year experience in a pharmaceutical/biotech setting
- Advanced technical expertise in databases, EDC platforms (e.g. Medidata Rave, Veeva), data imports/integrations and data visualization tools (e.g. Tableau, Spotfire)
- Advanced programming and analytical skills using SQL, BASE/SAS, SAS/STAT, SAS MACROS
- Ability to work independently to create standard datasets, program edit checks and produce quality data review outputs
- Demonstrated understanding of CDISC and SDTM requirements and implementation guidelines, able to create and validate CDISC standard datasets
- Knowledge of ICH GCP and Good Clinical Data Management guidelines
- Python programming language is a plus
Benefits
- Annual performance bonus
- Company equity
- For BridgeBio Full-Time U.S Based Roles: 401(k) with employer match
- For BridgeBio Full-Time U.S Based Roles: Employee Stock Purchase Program (ESPP)
- For BridgeBio Full-Time U.S Based Roles: Pre-tax commuter benefits (transit and parking)
- For BridgeBio Full-Time U.S Based Roles: Referral bonus for hired candidates
- For BridgeBio Full-Time U.S Based Roles: Subsidized lunch and parking on in-office days
- For BridgeBio Full-Time U.S Based Roles: 100% employer-paid medical, dental, and vision premiums for you and your dependents
- For BridgeBio Full-Time U.S Based Roles: Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- For BridgeBio Full-Time U.S Based Roles: Fertility & family-forming benefits
- For BridgeBio Full-Time U.S Based Roles: Expanded mental health support (therapy and coaching resources)
- For BridgeBio Full-Time U.S Based Roles: Hybrid work model with flexibility
- For BridgeBio Full-Time U.S Based Roles: Flexible, “take-what-you-need” paid time off and company-paid holidays
- For BridgeBio Full-Time U.S Based Roles: Comprehensive paid medical and parental leave to care for yourself and your family
- For BridgeBio Full-Time U.S Based Roles: Opportunities for skill development and internal mobility
- For BridgeBio Full-Time U.S Based Roles: Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- For BridgeBio Full-Time U.S Based Roles: Financial rewards, peer-to-peer recognition, and growth opportunities for strong performance
Company Overview
Company H1B Sponsorship