Principal Clinical Database Systems Programmer
New
B
BridgeBioClinical data systems
Location: Remote - USA; This is a U.S.-based remote roleFull-TimePrincipal
Salary$172,000 — $188,600 USD
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Job Details
- Experience
- Minimum 5-7 year experience in a pharmaceutical/biotech setting
- Required Skills
- SQLTableau
Requirements
- Have a bachelor’s degree or equivalent in science, computer systems, or an IT background.
- Have at least 5–7 years of experience in a pharmaceutical or biotech setting.
- Bring advanced programming and analytical skills using SQL, BASE/SAS, SAS/STAT, and SAS MACROS.
- Have advanced technical expertise in databases, EDC platforms, data imports and integrations, and data visualization tools.
- Demonstrate understanding of CDISC and SDTM requirements and implementation guidelines.
- Be able to create and validate CDISC standard datasets.
- Have knowledge of ICH GCP and Good Clinical Data Management guidelines.
- Be able to work independently to create standard datasets, program edit checks, and produce quality data review outputs.
- Be available for less than 10% travel to BridgeBio Headquarters or Biometrics/DM meetings, as required.
- Python programming is a plus.
Responsibilities
- Create standard and custom programs and reports using SAS, Tableau, or other data visualization tools to support data oversight and review.
- Lead EDC database build programming, testing, and migration of CRFs, edit checks, and dynamics using platforms such as Veeva Vault or Medidata Rave.
- Collaborate with clients, peers, programmers, project teams, and requestors to clarify and finalize data specifications.
- Support the development, delivery, and maintenance of clinical data review standards, tools, and systems across clinical, safety, and operational data sources.
- Support data review bridging and database development activities for Data Management and Clinical Programming.
- Assist with external vendor data imports and integrations in partnership with the Data Management Lead, and liaise with vendors on transfers and specifications.
- Assist in reviewing and approving study documentation, including design specifications, user requirements, data transfer specifications, and data standards.
- Provide leadership, training, guidance, and support to department members on data review tools and clinical database development.
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