Clinical Data Analyst — R&D Data & Regulatory Support

Ad Astra Diagnostics; Morrisville (NC); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k

Paid vacation

Life AD&D insurance

Short-term disability

Long-term disability

Job summary

Ad Astra Diagnostics in Morrisville, NC seeks a mid-level Clinical Data Analyst to manage and analyze R&D and clinical trial data for in vitro diagnostics development.

You will extract, clean, transform data, perform statistical analyses, and support regulatory submissions while communicating results to cross-functional teams. This role requires MS in Statistics/ Biostatistics or related field and 2–4 years of data analysis experience.

Qualifications

• MS in Statistics, Biostatistics, Data Science, Bioinformatics, or related field (or equivalent experience).
• 2-4 years of experience analyzing laboratory, clinical research, or clinical trial data.
• Experience with data cleaning.
• Familiarity with regression, ROC curves, hypothesis testing, confidence intervals, and study design.

Responsibilities

• Extract data from diverse sources while protecting PHI under HIPAA.
• Process and verify data integrity through the data lifecycle.
• Develop and maintain data collection, cleaning, and transformation workflows.
• Analyze performance data to support development, verification, and regulatory activities.
• Design and run statistical analyses including diagnostic performance studies.
• Support ML model development through data prep and evaluation.
• Perform ad-hoc analyses and present results to teams.
• Prepare reports and communications for internal and external audiences.

Skills

Data cleaning

Regression analysis

Hypothesis testing

ROC curves

Sensitivity/Specificity

Sample size determination

Data visualization

Communication

Independent work

Statistical programming

Education

MS in Statistics, Biostatistics, Data Science, or related field

Tools

R

Python

Excel

Word

Job description

Ad Astra Diagnostics in Morrisville, NC seeks a mid-level Clinical Data Analyst to manage and analyze R&D and clinical trial data for in vitro diagnostics development.

You will extract, clean, transform data, perform statistical analyses, and support regulatory submissions while communicating results to cross-functional teams. This role requires MS in Statistics/ Biostatistics or related field and 2–4 years of data analysis experience.