Principal Data Engineer (Biometrics)

Location: On-site in San Diego, California, United States

Annual base salary: $132,700–$182,000; annual bonus target of 30% of earned base salary and eligibility for an equity-based long-term incentive program.

Company

hirify.global is a biopharmaceutical company developing and commercializing treatments for neurological, psychiatric, endocrine, and immunological disorders.

What you will do

• Design, develop, implement, and maintain complex data engineering solutions supporting Clinical Data Management, Statistical Programming, and Biostatistics.
• Build and maintain pipelines moving clinical data from EDC, eCOA, central labs, and other vendors into CDISC-compliant, analysis-ready datasets.
• Automate CDISC workflows, including CDASH-aligned collection, SDTM generation, ADaM and TFL production, and end-to-end traceability.
• Develop data-quality tools, automated checks, outlier detection, and automation for study start-up, EDC database builds, protocol-to-SAP, and SAP-to-TFL workflows.
• Apply SDLC and computer system validation practices in GxP environments, including requirements, risk assessment, testing, traceability, change control, and release documentation.
• Partner with clinical, platform, AI engineering, integration, and vendor stakeholders to deliver scalable tools, support adoption, provide training, and measure improvements in usage, time saved, and quality.

Requirements

• Bachelor’s degree in Computer Science, Engineering, Bioinformatics, Statistics, or a related field plus 6+ years in data engineering, statistical programming, or clinical data management, including regulated clinical work; or a master’s degree in one of these fields plus 4+ years of relevant experience.
• Advanced knowledge of CDISC standards, including CDASH, SDTM, ADaM, controlled terminology, and define.xml, across clinical data collection, analysis, and regulatory submission.
• 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 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 with cloud computing platforms and GxP software validation, CSV/CSA, 21 CFR Part 11, 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 for regulated environments.
• Working knowledge of statistical concepts and methods, including descriptive statistics, probability, and hypothesis testing.
• Experience in the biopharmaceutical industry or a CRO supporting clinical trials.
• Ability to resolve complex technical and business problems, evaluate alternatives, consider cross-functional impacts, and implement scalable improvements.
• Strong analytical, critical-thinking, problem-solving, communication, collaboration, influencing, organization, and prioritization skills.
• Ability to provide technical guidance, contribute to best practices, support less-experienced colleagues without direct supervisory authority, and lead complex projects with competing priorities.

Nice to have

• Familiarity with Databricks and/or Spark.

Culture & Benefits

• On-site work in San Diego, California.
• Retirement savings plan with company match.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Annual bonus target of 30% of earned base salary and equity-based long-term incentive eligibility.
• Workplace focused on belonging, respect, empowerment, and equal employment opportunity.