Senior Clinical Data Analyst

BioTalent; San Diego (CA); Hybrid; USD 110,000 - 140,000; Full time

Job summary

BioTalent is recruiting a Clinical Data Analyst for a medical device startup in San Diego. The role focuses on monitoring clinical trial data, dashboards, and reporting to support FDA submission efforts.

Responsibilities include data quality checks, dataset preparation, and collaboration with cross-functional teams to drive regulatory submissions and HEOR analyses as needed.

Qualifications

• 5+ years in data analysis, clinical analytics or biostatistics support in medical devices, pharma, or clinical research.
• Knowledge of clinical trial methodology: endpoints, protocol adherence, safety monitoring, database lock, and GCP.
• Hands-on with clinical trial datasets including EDC outputs and device data.

Responsibilities

• Monitor daily clinical trial data across active studies, including pivotal FDA submission trials.
• Own and extend the clinical monitoring dashboard for outcomes, device performance, safety signals, and data completeness.
• Build monitoring tools for internal clinical, regulatory teams, CROs, and site PIs/coordinators.

Skills

SQL

Python/R

Data modeling

BigQuery

Dashboarding

Clinical data analysis

Communication

Education

MS in biostatistics or related field

Tools

Castor

Job description

Clinical Data Analyst | Medical Device Startup | San Diego, CA (Hybrid, 3+ days onsite)

A venture-backed startup developing a novel wearable medical device is hiring a Clinical Data Analyst. The company is running multiple clinical trials leading toward a pivotal FDA submission.

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 submission
• Own and extend the clinical monitoring dashboard, covering clinical outcomes, device performance, safety signals and data completeness
• Build monitoring tools for different user groups: internal clinical and regulatory teams, CROs, and site PIs and coordinators
• Define data quality checks, and triage and elevate anomalies, missing data and out-of-range values
• Produce recurring and ad hoc analyses of clinical outcomes, device performance and safety summaries
• Write reports for clinical, regulatory and leadership audiences, and contribute to regulatory submissions and publications
• Support execution of statistical analysis plans and run HEOR analyses for payers
• Write and own the SQL that turns warehoused clinical data into analysis-ready datasets
• Manage a visible queue of analytics requests, set priorities and commit to delivery dates
• Document analytical methods, dataset definitions and reporting standards

WHAT YOU BRING

• 5+ years in data analysis, clinical analytics or biostatistics support within medical devices, pharma or clinical research
• Working knowledge of clinical trial methodology: endpoints, protocol adherence, safety monitoring, database lock and GCP
• Hands-on experience with clinical trial datasets, including EDC outputs and device data
• Strong SQL skills, including joins, window functions and data modeling, plus BigQuery or a comparable cloud data warehouse
• Proficiency in Python or R, with work that is clean and reproducible
• Experience building and maintaining dashboards that other people rely on
• Ownership of analytical workstreams from start to finish while juggling competing deadlines
• Clear written and verbal communication with both technical and non-technical audiences
• Comfort working within regulated documentation and traceability requirements

NICE TO HAVE

• Experience with wearable or connected medical device data
• Contributions to FDA submissions or regulatory-facing clinical reports
• Familiarity with CDISC (SDTM/ADaM), HEOR modeling or EDC platforms such as Castor
• MS in biostatistics, epidemiology, biomedical engineering, data science or a related field

Candidates must be authorized to work in the U.S. without sponsorship and must live within commuting distance of San Diego.