Principal Data Engineer, Biometrics

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 is seeking a Principal Data Engineer, Biometrics to help design, develop, implement, and maintain GxP-compliant data engineering solutions for its clinical programs. In this onsite role based in San Diego, CA, you will build standards-driven data products that support Clinical Data Management, Statistical Programming, and Biostatistics, from clinical data collection through analysis datasets and ultimately regulatory submission.

This position focuses on applying CDISC standards fluency, automating the CDISC data flow, and delivering scalable, production-grade pipelines in a regulated environment with clear traceability and documentation.

What you’ll do

• Partner cross-functionally with Clinical Data Management, Statistical Programming, and Biostatistics to evaluate complex workflows, define solution requirements, and establish measurable success criteria for data engineering initiatives
• Convert Biometrics processes into maintained, production-grade data products with clear ownership, versioning, and support
• Design, build, and maintain pipelines that transform 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 dataset generation, and support for ADaM and TFL production, while maintaining end-to-end traceability
• Create data quality and review tools, including automated checks and outlier detection, to move from manual inspection to exception-based review
• Develop tools that reduce study start-up effort, such as protocol-to-SoA-to-CRF review, standards-based EDC database builds, and protocol-to-SAP plus SAP-to-TFL shell automation
• Support Medical Writing and Biostatistics with automated, standards-driven document outputs
• Define vendor data transfer specifications and implement direct vendor-to-EDC and vendor-to-lake transfers in collaboration with integration and platform colleagues
• Apply established SDLC and computer system validation practices for GxP systems, including requirements, risk assessment, testing, traceability, change control, and release documentation
• Enable adoption of delivered tools through user training, documentation, and feedback loops, measuring impact via usage, time saved, and quality improvements
• Coordinate with platform and AI engineering teams so Biometrics data products align with the enterprise data lake, governance model, and downstream analytics
• Act as a technical resource for Biometrics and Clinical stakeholders, providing recommendations, evaluating emerging technologies and vendors, and aligning solutions to business and technical needs
• Perform other job-related duties as assigned

Requirements

• Bachelor’s degree in Computer Science, Engineering, Bioinformatics, Statistics, or a related field AND 6+ years of experience 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: CDASH, SDTM, ADaM, controlled terminology, and define.xml, including how they apply across clinical data collection, analysis, and regulatory submission
• Experience designing, developing, and maintaining complex, production-grade data engineering solutions for clinical data management, statistical programming, or biostatistics
• Strong proficiency in Python and SQL, with database design and data modeling, with working knowledge of SAS and/or R
• Advanced software engineering practices, including Git/GitHub, CI/CD, automated testing, and maintainable code development
• Experience working with clinical data structures and integration across EDC, eCOA, CTMS, and external vendor systems
• Experience with cloud computing platforms, 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 practices
• Understanding of FDA clinical study data submission expectations, including the Study Data Technical Conformance Guide and tools such as Pinnacle 21
• Experience operationalizing AI/LLM workflows, including prompt and retrieval design, output evaluation, monitoring, and validation suitable for regulated environments
• Working knowledge of statistical concepts and methods, including descriptive statistics, probability, and hypothesis testing
• Experience in biopharmaceutical industry or a CRO supporting clinical trials
• Ability to analyze and resolve complex technical and business problems using sound judgment
• Strong analytical, critical thinking, and problem-solving skills with the ability to evaluate alternatives and consider cross-functional impacts
• Excellent communication and influencing skills to collaborate with cross-functional stakeholders and support solution adoption
• Demonstrated ability to provide technical guidance and support best practices, including mentoring less-experienced colleagues
• Strong organizational and prioritization skills to lead complex initiatives and deliver outcomes aligned with functional objectives
• Ability to identify continuous improvement opportunities and implement scalable solutions that enhance operational effectiveness

Salary and location

• Location: San Diego, CA (onsite)
• Salary: USD 132,700 - 182,000 per year

Tools and technologies you may use

• CDISC, CDASH, SDTM, ADaM, controlled terminology, define.xml
• 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, TFL, SoA, CRF, SAP, SDLC

Benefits

• Annual bonus with a target of 30% of earned base salary
• Eligibility for 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 including medical, prescription drug, dental, and vision coverage