Cdisc Standards Engineer 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

Lead the design and delivery of GxP-compliant clinical data engineering solutions across the CDISC standards workflow.

Responsibilities

Partner cross-functionally with Clinical Data Management, Statistical Programming, and Biostatistics to evaluate complex workflows, define 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 dataset generation, and support for ADaM and TFL production while maintaining end-to-end traceability
Build data quality and review capabilities, including automated checks and outlier detection, to enable exception-based review workflows
Develop tools to accelerate study start-up, including protocol-to-SoA-to-CRF review, standards-based EDC database build, 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 with integration and platform colleagues
Apply SDLC and computer system validation practices for GxP systems, including requirements, risk assessment, testing, traceability, change control, and release documentation for inspection-ready solutions
Enable adoption through user training, documentation, and feedback loops; measure impact via usage, time saved, and quality improvements
Collaborate with platform and AI engineering colleagues to align Biometrics data products with the enterprise data lake, governance model, and downstream analytics
Serve as a technical advisor to Biometrics and Clinical stakeholders by recommending solutions based on business and technical requirements and evaluating emerging technologies and vendors
Perform other job-related duties as assigned

Requirements

Bachelor’s Degree in Computer Science, Engineering, Bioinformatics, Statistics, or a related field AND 6+ years in data engineering, statistical programming, or clinical data management in a regulated clinical environment
OR Master’s Degree in Computer Science, Engineering, Bioinformatics, Statistics, or a related field AND 4+ years in data engineering, statistical programming, or clinical data management in a regulated clinical environment
Advanced knowledge of CDISC standards including CDASH, SDTM, ADaM, controlled terminology, and define.xml, including how they apply across collection, analysis, and regulatory submission
Proven experience building and maintaining complex, production-grade data engineering solutions supporting clinical data management, statistical programming, or biostatistics
Strong proficiency in Python, SQL, database design, and data modeling; working knowledge of SAS and/or R
Advanced knowledge of software engineering best practices, including 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 computing experience, preferably AWS; familiarity with Databricks and/or Spark is a plus
Experience applying GxP validation practices such as CSV/CSA, 21 CFR Part 11 requirements, and risk-based validation for regulated software solutions
Strong understanding 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 in 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
Demonstrated ability to analyze and resolve complex technical and business problems using sound judgment
Strong analytical and problem-solving skills with ability to evaluate alternatives and consider cross-functional impacts
Excellent communication and collaboration skills to influence cross-functional stakeholders and support alignment and adoption
Ability to provide technical guidance, contribute to best practices, and support less-experienced colleagues without direct supervisory authority
Strong organizational and prioritization skills to lead complex projects, manage competing priorities, and deliver results aligned with functional objectives
Ability to identify continuous improvement opportunities, recommend scalable process improvements, and enhance operational effectiveness

Technologies

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 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 including medical, prescription drug, dental, and vision coverage

Job Details

Location: San Diego, CA (onsite)
Salary: USD 132,700 - 182,000 per year
Experience: Minimum 4 years (based on degree)
Education: Bachelor’s or Master’s degree in a relevant field

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