Senior Clinical Data Analyst

THE ROLE: This role owns clinical trial monitoring, analysis and reporting, and reports to the Director of Data Science. You'll ramp up alongside a senior data scientist to take over the existing clinical reporting pipelines and dashboards (SQL, Python, TypeScript, Terraform), then own their further development. As the company approaches commercial scale, the role will expand into manufacturing, quality and business analytics.

WHAT YOU'LL DO: Monitor clinical trial data across active studies every day, including the trials supporting the pivotal FDA submissionOwn and extend the clinical monitoring dashboard, covering clinical outcomes, device performance, safety signals and data completenessBuild monitoring tools for different user groups: internal clinical and regulatory teams, CROs, and site PIs and coordinatorsDefine data quality checks, and triage and escalate anomalies, missing data and out-of-range valuesProduce recurring and ad hoc analyses of clinical outcomes, device performance and safety summariesWrite reports for clinical, regulatory and leadership audiences, and contribute to regulatory submissions and publicationsSupport execution of statistical analysis plans and run HEOR analyses for payersWrite and own the SQL that turns warehoused clinical data into analysis-ready datasetsManage a visible queue of analytics requests, set priorities and commit to delivery datesDocument analytical methods, dataset definitions and reporting standardsWHAT YOU BRING5+ years in data analysis, clinical analytics or biostatistics support within medical devices, pharma or clinical researchWorking knowledge of clinical trial methodology: endpoints, protocol adherence, safety monitoring, database lock and GCPHands-on experience with clinical trial datasets, including EDC outputs and device dataStrong SQL skills, including joins, window functions and data modeling, plus BigQuery or a comparable cloud data warehouseProficiency in Python or R, with work that is clean and reproducibleExperience building and maintaining dashboards that other people rely onOwnership of analytical workstreams from start to finish while juggling competing deadlinesClear written and verbal communication with both technical and non-technical audiencesComfort working within regulated documentation and traceability requirementsNICE TO HAVEExperience with wearable or connected medical device dataContributions to FDA submissions or regulatory-facing clinical reportsFamiliarity with CDISC (SDTM/ADaM), HEOR modeling or EDC platforms such as CastorMS in biostatistics, epidemiology, biomedical engineering, data science or a related fieldCandidates must be authorized to work in the U.S. without sponsorship and must live within commuting distance of San Diego.