Principal Data Engineer, Biometrics

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