Principal Clinical Database Systems Programmer

bridgebio; United States; Remoto; USD 172.000 - 189.000; Tempo integral

Benefícios oferecidos por esta vaga

Remote work (US-based)

Office visits in San Francisco

Medical, dental, vision coverage

Retirement matching

Paid leave & PTO

Professional development

Resumo da vaga

BridgeBio seeks a Lead Clinical Database Programmer to design, implement, and oversee clinical data systems across studies. You will program databases, listings, reports, and visualizations using SQL or SAS, and ensure quality through testing and validation.

Ideal candidates have 5–7 years in pharma/biotech, hands-on experience with Medidata Rave or Veeva, and strong CDISC/SDTM knowledge. This US-based remote role includes SF office visits and comprehensive benefits.

Qualificações

• Bachelor’s degree or equivalent in science, computer systems, or information technology.
• 5–7 years of experience in pharmaceutical or biotechnology settings.
• Advanced programming and analytical skills with SQL and SAS, including BASE/SAS, SAS/STAT, and SAS macros.
• Experience with clinical databases and EDC systems such as Medidata Rave or Veeva; ability to create datasets, edit checks, and data review outputs.
• Understanding of CDISC and SDTM requirements, including standard datasets creation and validation.
• Knowledge of ICH Good Clinical Practice and Good Clinical Data Management guidelines.

Responsabilidades

• Build and maintain clinical data systems, including study databases, programmed listings, reports, and visualizations using SQL or SAS and related tools.
• Lead electronic data capture database programming, testing, and migration of CRFs, edit checks, and database configurations.
• Clarify study specifications with project partners and translate requirements into reliable programming and data structures.
• Develop and maintain standards, tools, and systems for reviewing clinical, safety, and operational data.
• Coordinate external data imports and integrations with data management leads and vendors; support transfer specifications.
• Review study documentation such as design specifications, user requirements, data transfer specifications, and data standards.
• Provide technical guidance and training to colleagues working on clinical database development and data review tools.

Conhecimentos

SQL

SAS

BASE/SAS

SAS/STAT

SAS macros

Medidata Rave

Veeva

CDISC/SDTM

ICH GCP

Python

Formação

Bachelor’s degree in science / IT

Ferramentas

Medidata Rave

Veeva

Descrição da vaga

Role overview

Lead clinical database programming and data review systems work across one or more studies. The role builds and maintains clinical data collection systems, produces review outputs, and coordinates study requirements with data management, clinical development, biostatistics, project teams, and external data vendors.

Responsibilities

• Build and maintain clinical data systems, including study databases, programmed listings, reports, and visualizations using SQL or SAS and related tools.
• Lead electronic data capture database programming, testing, and migration of case report forms, edit checks, and database configurations.
• Clarify study specifications with project partners and translate requirements into reliable programming and data structures.
• Develop and maintain standards, tools, and systems for reviewing clinical, safety, and operational data.
• Coordinate external data imports and integrations with data management leads and vendors; support transfer specifications.
• Review study documentation such as design specifications, user requirements, data transfer specifications, and data standards.
• Provide technical guidance and training to colleagues working on clinical database development and data review tools.

Requirements

• Bachelor’s degree or equivalent background in science, computer systems, or information technology.
• 5–7 years of experience in pharmaceutical or biotechnology settings.
• Advanced programming and analytical skills with SQL and SAS, including BASE/SAS, SAS/STAT, and SAS macros.
• Experience with clinical databases and EDC systems, such as Medidata Rave or Veeva, and ability to independently create datasets, edit checks, and data review outputs.
• Understanding of CDISC and SDTM requirements, including creating and validating standard datasets.
• Knowledge of ICH Good Clinical Practice and Good Clinical Data Management guidelines.

Nice to have

• Python programming and experience with data visualization tools such as Tableau or Spotfire.

Benefits and work setup

The role is U.S.-based and remote, with quarterly or as-needed visits to an office in San Francisco. Listed annual salary is $172,000–$188,600. U.S. full-time benefits described in the source include employer-paid medical, dental, and vision coverage, retirement matching, paid leave, flexible paid time off, and professional development opportunities.