Senior Data Analyst, Clinical Monitoring & Analysis

Job description

Senior Data Analyst, Clinical Monitoring & Analysis Luna Health created Sleep-Only Automation™: insulin delivery that works while you sleep and disappears when you wake. We're a venture-backed medical device startup that makes the world's smallest 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. They don't need a full replacement of their chosen therapy, they need protection while they sleep. Our founders have lived this problem as people with diabetes and as parents of children with diabetes, and they have built some of the most recognized products in the space. Now we are building the answer to a question the industry left unanswered: what do pen users need at night that no one has built yet. Sleep-Only Automation™ is it. The Role We are seeking a Senior Clinical Data Analyst to own clinical trial monitoring, analysis, and reporting at Luna Health, reporting to the Director of Data Science. This role is the clinical data heartbeat of the team. With several trials past, present, and planned, Luna needs you to 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 over the first few months to take ownership of the existing clinical reporting pipelines and dashboards (SQL, python, TypeScript, Terraform), then you will 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 to follow the thread through messy data. As we approach commercial scale, this role broadens beyond clinical. The same instincts that make trial data trustworthy apply to manufacturing, quality, and business analytics, and we expect this role to grow into that scope over time. This is an onsite/hybrid role (3+ days/week) in our San Diego office, and you must live within a reasonable commuting distance. 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. Responsibilities Analysis and reporting 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 Trial monitoring and data quality Own and extend the clinical monitoring dashboard, including glycemic outcomes, device performance, safety signals, and data completeness. This is a custom tool built using python, SQL, TypeScript, and Terraform. 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 Data and delivery 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 What You Bring 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. Current dashboards use a custom stack: python, SQL, TypeScript, and Terraform. 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 Nice to Have 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 What Success Looks Like Within six months, you are running clinical monitoring independently and further trials start with you at the wheel Trial data problems surface in days rather than at database lock Clinical, regulatory, and leadership treat you as the single trusted source for what the trial data says, and know when to expect an answer What We Offer A no-jerk policy — we seek the best and brightest talent who are fun to work with Equity — we are just setting off on this journey, and you will get in from the start Excellent health benefits — we depend on it ourselves as a team that has or cares for people with diabetes What to Expect The first step is to apply for this job on our website. Next, we will schedule a virtual interview with the hiring manager to introduce you to the company and the role. Finally, we will invite you on-site to discuss your experience and meet the team. We are in a hurry to find the right person – not in a hurry to hire – so we will take time getting to know you and making sure that you will be an excellent fit for the work that we are doing. An Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Physical Demands The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Sit for extended periods of time at a keyboard and mouse Lift and move up to 25lbs Work in a second story office up a flight of stairs Hearing and speaking will be required regularly Specific vision abilities including close and distance vision, depth perception, peripheral vision, and the ability to adjust focus To All Staffing and Recruiting Agencies This posting is only for individuals seeking a job at Luna Health. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Luna Health does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to Luna Health. Luna Health is not responsible for any fees related to unsolicited resumes/applications.