Principal Data Engineer, Biometrics
Neurocrine Biosciences, Inc.2 days ago
San Diego, CA, USAStaff+
Base Salary
$133k - $182k/yr
Responsibilities
- Collaborate with Clinical Data Management, Statistical Programming, and Biostatistics to assess workflows, define requirements, and establish measurable outcomes.
- Translate Biometrics processes into production-grade, versioned, supported data products.
- Design, build, and maintain pipelines moving clinical data from EDC, eCOA, central laboratories, and vendors into standards-compliant analysis datasets.
- Automate CDISC data flows, including CDASH-aligned collection, SDTM generation, and support for ADaM and TFL production with end-to-end traceability.
- Develop automated data-quality checks, outlier detection, and exception-based review tools.
- Build study start-up automation for protocol-to-SoA-to-CRF review, standards-based EDC database builds, and protocol-to-SAP and SAP-to-TFL shell workflows.
- Support automated standards-driven document outputs for Medical Writing and Biostatistics.
- Define vendor data-transfer specifications and implement vendor-to-EDC and vendor-to-data-lake integrations.
- Apply SDLC and computer system validation practices, including requirements, risk assessment, testing, traceability, change control, and release documentation.
- Support implementation through training, documentation, feedback, and measurement of usage, time savings, and quality improvements.
- Collaborate with platform and AI engineering teams to align Biometrics products with the enterprise data lake and governance model.
- Provide technical guidance to clinical stakeholders and evaluate technologies and vendor solutions.
Requirements
- Bachelor's degree in Computer Science, Engineering, Bioinformatics, Statistics, or a related field plus 6+ years of relevant experience, or a master's degree in one of those fields plus 4+ years of relevant experience.
- Experience in data engineering, statistical programming, or clinical data management within a regulated clinical environment.
- Advanced knowledge of CDISC standards, including CDASH, SDTM, ADaM, controlled terminology, and define.xml.
- Experience designing, developing, and maintaining complex production-grade data engineering solutions for clinical data, 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 practices, including Git/GitHub, automated testing, and maintainable code development.
- Experience integrating clinical data across EDC, eCOA, CTMS, and external vendor systems.
- Experience with cloud computing platforms, preferably AWS; Databricks and/or Spark experience is preferred.
- Experience applying GxP software validation, CSV/CSA, 21 CFR Part 11, and risk-based validation practices.
- Understanding of FDA clinical study data submission expectations, the Study Data Technical Conformance Guide, and tools such as Pinnacle 21.
- Experience operationalizing AI/LLM workflows involving prompt and retrieval design, output evaluation, monitoring, and validation in regulated environments.
- Working knowledge of descriptive statistics, probability, and hypothesis testing.
- Experience in biopharmaceutical or CRO environments supporting clinical trials.
- Ability to solve complex technical and business problems, provide technical guidance, lead complex initiatives, and support less-experienced colleagues without direct supervisory authority.
- Strong analytical, communication, collaboration, influencing, organizational, prioritization, and continuous-improvement skills.
Benefits
- Annual bonus target of 30% of earned base salary and eligibility for an equity-based long-term incentive program.
- 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.
- Annual base salary range of $132,700.00-$182,000.00, with pay decisions based on location, role complexity, duties, experience, and skills.
Tech Stack
Categories
Data Engineering
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a public biopharmaceutical company that discovers, develops, and commercializes treatments for neurological, psychiatric, and endocrine disorders. Its portfolio includes valbenazine (INGREZZA) for tardive dyskinesia and Huntington’s chorea, and AbbVie-partnered elagolix therapies for endometriosis and uterine fibroids. Founded in 1992 and headquartered in San Diego, it sells prescription medicines primarily in the U.S. and advances a pipeline across CNS and related indications.