Senior Data Analyst, Clinical Monitoring & Analysis

Luna Health•San Diego, CA

3d•Hybrid

About The Position

Luna Health created Sleep-Only Automation™, a small insulin patch pump designed to provide nighttime glucose control for Type 1 and Type 2 diabetes insulin users who manage their days well and have made a considered choice to stay on pens. We are seeking a Senior Clinical Data Analyst to own clinical trial monitoring, analysis, and reporting. This role is the clinical data heartbeat of the team. You will monitor trial data in real time, ensure data quality, surface findings to clinical and regulatory stakeholders, and produce the analyses and reports that inform both internal decisions and external submissions. You'll work closely with our senior data scientist to take ownership of existing clinical reporting pipelines and dashboards (SQL, python, TypeScript, Terraform), then own further development and analysis. We're looking for someone with solid clinical data experience and statistical depth, comfortable in a regulated environment, and able to communicate findings clearly to non-technical audiences. This is an execution and storytelling role that requires reliability, attention to detail, and good instincts. As we approach commercial scale, this role broadens beyond clinical to manufacturing, quality, and business analytics.

Requirements

5+ years in data analysis, clinical analytics, biostatistics support, or a closely related role in medical devices, pharma, or clinical research
Solid working knowledge of clinical trial methodology. endpoint definitions, protocol adherence, safety monitoring, database lock, and Good Clinical Practice expectations
Demonstrated experience with clinical trial datasets, including EDC outputs and device data
Strong SQL, including joins, aggregations, window functions, and data modeling concepts; hands-on experience with BigQuery or a comparable cloud warehouse
Working proficiency in Python (or R) for analysis, visualization, and reporting. Work is clean, reproducible, and can be read and rerun by someone else
Experience building and maintaining dashboards that other people depend on, and the judgment to decide what belongs on them.
A track record of owning analytical workstreams end to end under competing deadlines, including the willingness to sequence work and negotiate scope with stakeholders
Ability to communicate analytical findings clearly, in writing and in presentation, to technical and non-technical audiences
Attention to detail, a strong instinct for data quality, and the initiative to trace things that don't look right
Comfort in a regulated environment, with rigid documentation and traceability requirements
Must live within a reasonable commuting distance to our San Diego office.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

Experience with diabetes, CGM, or automated insulin delivery data
Experience contributing to FDA submissions or regulatory-facing clinical reports
Familiarity with CDISC standards (SDTM/ADaM) or HEOR modeling
Experience with EDC platforms, like Castor CDMS
Interest in growing into manufacturing, quality, or commercial analytics as we approach approval
MS in biostatistics, epidemiology, biomedical engineering, data science, or a related field

Responsibilities

Produce recurring and ad hoc analyses of trial data, including glycemic outcomes, device performance, safety summaries
Write clear, accurate reports for clinical, regulatory, and leadership audiences, and contribute analytical content to regulatory submissions and publications.
Support statistical analysis plan execution.
Execute health economic outcomes research (HEOR) analyses demonstrating device value to payers
Own and extend the clinical monitoring dashboard, including glycemic outcomes, device performance, safety signals, and data completeness.
Develop clinical monitoring tools for different user tiers, for example internal clinical/regulatory, external CRO, and external trial Site PIs or coordinators
Own day-to-day monitoring of clinical trial data across active studies, including the trials leading to our pivotal FDA submission
Define the checks that catch problems early. Identify, triage, and escalate anomalies, missing data, and out-of-range values with the clinical, regulatory, and engineering teams
Write and own the SQL that turns warehoused clinical data into analysis-ready datasets, and partner with our senior data engineer on what belongs in the pipeline versus the analysis layer
Combine modern AI tools and software development best practices to build and maintain data products and tools used across the enterprise
Keep a visible queue of analytics requests across clinical, regulatory, and leadership. Assess priority, commit to dates, and identify recurring questions as reporting or dashboarding needs.
Maintain clear documentation of analytical methods, dataset definitions, and reporting standards