Clinical Data Management Jobs

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Today

Principal Data Engineer, Biometrics

Neurocrine Bioscience San Diego, CA

San Diego, CA

Today

$133k - $182k/yr Full time Cdisc Standards Clinical Data Engineer Clinical Data Engineering

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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, including 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

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