Clinical Data Analyst — R&D Data & Regulatory Support

Adastradx; Morrisville (NC); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401k plan

Paid vacation

Life AD&D insurance

Short-term and long-term disability

Job summary

Ad Astra Diagnostics (AAD) is seeking a mid-level Clinical Data Analyst to manage and analyze R&D experimental and clinical trial data as we develop in vitro diagnostic devices for clinical laboratories and clinical decision support software. The role focuses on handling PHI data under HIPAA and ensuring data integrity across the data lifecycle.

Responsibilities include data extraction, cleaning, statistical analyses (ROC, sensitivity/specificity), model support, and reporting.

Qualifications

• MS in Statistics, Biostatistics, Data Science, Bioinformatics, or a related field, or equivalent industry experience.
• 2-4 years of experience analyzing laboratory, clinical research, or clinical trial data.
• Experience with data cleaning.
• Experience with Regression Analysis, Accuracy and Precision, Hypothesis Testing, Confidence Intervals, ROC Curves, Sensitivity/Specificity, and Sample Size Determination.
• Familiarity with Microsoft Excel and Word.
• Demonstrated technical ability with R, Python, or equivalent statistical analysis software.
• Strong written and verbal communication skills.
• Data visualization and reporting techniques.
• Ability to work independently in a fast-paced, multidisciplinary environment.

Responsibilities

• Extract data from laboratory instruments, clinical trial databases, and internal/external sources containing PHI under HIPAA laws and regulations, verifying integrity and traceability.
• Process and verify the integrity of data used for analysis through the data lifecycle.
• Develop and maintain data collection, data cleaning, and data transformation procedures and workflows.
• Compile, analyze, and interpret performance data in support of development, verification, validation, and regulatory activities.
• Design and execute statistical analyses, including accuracy, precision, agreement, and diagnostic performance studies.
• Support development and validation of machine learning models through data preparation, performance analysis, and feature evaluation.
• Perform ad-hoc analysis and present results to multidisciplinary teams.
• Assist and prepare reports and written communication for internal and external audiences.

Skills

Data cleaning

Regression analysis

Accuracy & precision

Hypothesis testing

Confidence intervals

ROC curves

Sensitivity/specificity

Sample size determination

R

Python

Data visualization

Reporting

Written & verbal communication

Independent work

Education

MS in Statistics/Biostatistics/Data Science/Bioinformatics or related field

Tools

Excel

Word

Job description

Ad Astra Diagnostics (AAD) is seeking a mid-level Clinical Data Analyst to manage and analyze R&D experimental and clinical trial data as we develop in vitro diagnostic devices for clinical laboratories and clinical decision support software. The role focuses on handling PHI data under HIPAA and ensuring data integrity across the data lifecycle.

Responsibilities include data extraction, cleaning, statistical analyses (ROC, sensitivity/specificity), model support, and reporting.