Principal Data Engineer, Biometrics

Neurocrine Biosciences • San Diego, CA

3d • $132,700 - $182,000

About The Position

The Principal Data Engineer, Biometrics is an experienced data engineering professional responsible for designing, developing, implementing, and maintaining complex data engineering solutions that support Neurocrine's Clinical programs, including Clinical Data Management, Statistical Programming, and Biostatistics. The role supports the regulated data path from clinical data collection through analysis datasets and regulatory submissions. It requires fluency in CDISC standards and clinical data models, along with the software engineering discipline to build, validate, and maintain tools in a GxP environment. The work aims to accelerate study database builds, improve data quality, increase efficiency in dataset and output generation, and help Biometrics scale as the pipeline grows.

The position analyzes and resolves complex technical challenges, partners across functions to assess needs, recommends solutions, and implements scalable improvements. It contributes to technical standards and best practices and supports solution adoption through documentation, training, and ongoing support.

Neurocrine Biosciences is a biopharmaceutical company focused on discovering, developing, and commercializing treatments for neurological, psychiatric, endocrine, and immunological disorders.

Requirements

• Bachelor's degree in Computer Science, Engineering, Bioinformatics, Statistics, or a related field and 6 or more years of experience in data engineering, statistical programming, or clinical data management, including work in a regulated clinical environment; or a master's degree in one of these fields and 4 or more years of such experience.
• Advanced knowledge of CDISC standards, including CDASH, SDTM, ADaM, controlled terminology, and define.xml, and their application across clinical data collection, analysis, and regulatory submission.
• Demonstrated experience designing, developing, 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, with 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.
• Experience applying GxP software validation (CSV/CSA), 21 CFR Part 11 requirements, and risk-based validation practices to 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 appropriate for regulated environments.
• Working knowledge of statistical concepts and methods, including descriptive statistics, probability, and hypothesis testing.
• Experience in the biopharmaceutical industry or a contract research organization supporting clinical trials.
• Demonstrated ability to analyze and resolve complex technical and business problems using sound judgment to develop effective solutions.
• Strong analytical, critical-thinking, and problem-solving skills, including the ability to evaluate alternatives and cross-functional impacts.
• Excellent communication, collaboration, and influencing skills, with the ability to support stakeholder 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, including the ability to lead complex projects, manage competing priorities, and deliver results aligned with functional objectives.
• Ability to identify opportunities for continuous improvement and implement process improvements and scalable solutions.

Nice To Haves

• Experience with cloud computing platforms, preferably AWS.
• Familiarity with Databricks and/or Spark.

Responsibilities

• Collaborate with Clinical Data Management, Statistical Programming, and Biostatistics to evaluate workflows, identify improvement opportunities, define solution requirements, and establish measurable success criteria.
• Translate Biometrics processes into maintained, production-grade data products with clear ownership, versioning, and support.
• Design, build, and maintain pipelines that move clinical data from collection systems, including EDC, eCOA, central laboratories, and other vendors, into standards-compliant, analysis-ready datasets.
• Develop automation across the CDISC data flow, including CDASH-aligned collection, SDTM dataset generation, and support for ADaM and TFL production, maintaining end-to-end traceability.
• Build data quality and review tools, including automated checks and outlier detection, to support exception-based review workflows.
• Develop tools to accelerate study start-up, including protocol-to-SoA-to-CRF review, standards-based EDC database builds, and protocol-to-SAP and SAP-to-TFL shell automation.
• Support Medical Writing and Biostatistics with automated, standards-driven document outputs.
• Assist in defining vendor data transfer specifications and implementing direct vendor-to-EDC and vendor-to-lake transfers with integration and platform colleagues.
• Apply SDLC and computer system validation practices for GxP-related systems, including requirements, risk assessment, testing, traceability, change control, and release documentation.
• Support implementation and adoption of delivered tools through user training, documentation, and ongoing feedback; measure impact through 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 resource and advisor to Biometrics and Clinical stakeholders, providing recommendations and evaluating emerging technologies and vendor solutions.
• Perform other job-related duties as assigned.

Benefits

• Retirement savings plan with company match.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.
• Annual bonus with a target of 30% of earned base salary.
• Eligibility to participate in an equity-based long-term incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal