Neurocrine Bioscience is hiring a Principal Data Engineer (Biometrics) to help build and scale GxP-compliant data engineering solutions for clinical programs. You will work on a regulated data path that runs from clinical collection through analysis-ready datasets and regulatory submission support, partnering closely with Clinical Data Management, Statistical Programming, and Biostatistics.
What you’ll do
- Collaborate cross-functionally to evaluate complex workflows, identify improvement opportunities, define solution requirements, and establish measurable success criteria for data engineering initiatives
- Translate Biometrics processes into production-grade data products with clear ownership, versioning, and support
- Design, build, and maintain pipelines that move clinical data from EDC, eCOA, central labs, and other vendors into standards-compliant, analysis-ready datasets
- Automate the CDISC data flow, including CDASH-aligned collection, SDTM generation, and support for ADaM and TFL production while maintaining end-to-end traceability
- Build data quality and review tooling, such as automated checks and outlier detection, to support exception-based review workflows
- Develop tools that accelerate study start-up, including protocol-to-SoA-to-CRF review, standards-based EDC database builds, and shell automation for protocol-to-SAP and SAP-to-TFL
- Support Medical Writing and Biostatistics with automated, standards-driven document outputs
- Assist with vendor data transfer specifications and implement direct vendor-to-EDC and vendor-to-lake transfers in partnership with integration and platform colleagues
- Apply established SDLC and computer system validation practices for GxP-related systems, including requirements, risk assessment, testing, traceability, change control, and release documentation
- Support adoption through training, documentation, feedback loops, and measurement of impact using usage, time saved, and quality improvements
- Partner with platform and AI engineering so Biometrics data products align with the enterprise data lake, governance model, and downstream analytics
- Serve as a technical advisor to Biometrics and Clinical stakeholders by recommending solutions that address business and technical requirements and evaluating emerging technologies
Required experience and skills
- Bachelor’s degree in Computer Science, Engineering, Bioinformatics, Statistics, or related field AND 6+ years in data engineering, statistical programming, or clinical data management in a regulated clinical environment, OR Master’s degree and 4+ years in the same areas
- Advanced knowledge of CDISC standards including CDASH, SDTM, ADaM, controlled terminology, and define.xml, including how they apply from collection to analysis and regulatory submission
- Proven experience designing, developing, and maintaining complex, production-grade data engineering solutions supporting clinical data management, statistical programming, or biostatistics
- Strong proficiency in Python and SQL, plus database design and data modeling; working knowledge of SAS and/or R
- Advanced software engineering practices: Git/GitHub, CI/CD, automated testing, and maintainable code development
- Experience with clinical data structures and integration across EDC, eCOA, CTMS, and external vendor systems
- Cloud experience, preferably AWS; familiarity with Databricks and/or Spark is a plus
- Experience applying GxP software validation (CSV/CSA), 21 CFR Part 11, and risk-based validation approaches for regulated software
- Knowledge of FDA clinical study data submission expectations, including the Study Data Technical Conformance Guide and conformance tools such as Pinnacle 21
- Experience operationalizing AI/LLM workflows including prompt and retrieval design, output evaluation, monitoring, and validation for regulated environments
- Working statistical knowledge (descriptive statistics, probability, hypothesis testing)
- Experience in biopharmaceutical industry or CRO environment supporting clinical trials
Compensation and benefits
- San Diego, CA (onsite)
- Salary: USD 132,700 - 182,000 per year
- Annual bonus with target of 30% of the earned base salary
- Eligibility to participate in an equity-based long-term incentive program
- Retirement savings plan with company match
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision
Tools and standards you’ll work with
CDISC (CDASH, SDTM, ADaM, controlled terminology, define.xml), clinical systems (EDC, eCOA, CTMS), GxP, Python, SQL, SAS, R, Git/GitHub, CI/CD, Databricks, Spark, AWS, CSV/CSA, 21 CFR Part 11, Pinnacle 21, AI/LLM, and clinical artifacts such as TFL, SoA, CRF, and SAP.
