Principal Data Engineer, Biometrics — GxP CDISC Pipelines

Neurocrine Bioscience; San Diego (CA); On-site; USD 133,000 - 182,000; Full time

Benefits offered by this job

Annual bonus (target 30%)

Equity-based long term incentive

Retirement plan with company match

Paid vacation

Holiday and personal days

Paid caregiver/ parental and medical"

Job summary

Neurocrine Bioscience seeks a Principal Data Engineer, Biometrics to design, develop, and maintain GxP-compliant data pipelines for clinical programs in an onsite San Diego, CA role. Build standards-driven data products supporting Clinical Data Management, Statistical Programming, and Biostatistics from collection to regulatory submission.

The role emphasizes CDISC standards fluency, automating CDISC data flow, and delivering production-grade pipelines with traceability and documentation in a

Qualifications

• Bachelor’s degree in Computer Science, Engineering, Bioinformatics, Statistics, or related field with 6+ years in data engineering or Clinical Data Management; or Master’s with 4+ years

Responsibilities

• Partner cross-functionally with Clinical Data Management, Statistical Programming, and Biostatistics to define requirements and success criteria
• Convert Biometrics processes into production-grade data products with clear ownership and versioning
• Design, build, and maintain pipelines transforming data from EDC, eCOA, central labs into analysis-ready datasets
• Automate CDISC data flow including CDASH-aligned collection and SDTM dataset generation
• Support ADaM and TFL production with end-to-end traceability
• Create data quality and review tools, including automated checks and outlier detection
• Develop tools to reduce study start-up effort (protocol-to-SoA-to-CRF, etc.)
• Support Medical Writing and Biostatistics with automated document outputs
• Define data transfer specifications for vendor data transfers with integration teams
• Apply GxP validation practices (CSV/CSA), 21 CFR Part 11, risk-based validation
• Enable AI/LLM workflows in regulated environments
• Communicate effectively to stakeholders and mentor colleagues

Skills

Python

SQL

CDISC

GxP

Data modeling

SAS

R

Git/GitHub

CI/CD

Cloud (AWS)

Databricks

Spark

Education

Bachelor’s degree in CS/Engineering/Bioinformatics/Statistics or related

Master’s degree (4+ years experience)

Tools

Databricks

Spark

AWS

Git

Job description

Neurocrine Bioscience seeks a Principal Data Engineer, Biometrics to design, develop, and maintain GxP-compliant data pipelines for clinical programs in an onsite San Diego, CA role. Build standards-driven data products supporting Clinical Data Management, Statistical Programming, and Biostatistics from collection to regulatory submission.

The role emphasizes CDISC standards fluency, automating CDISC data flow, and delivering production-grade pipelines with traceability and documentation in a