Clinical Data Analyst & Biostatistics Expert

Ad Astra Diagnostics, Inc.; 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 (AAD) is seeking a mid-level Clinical Data Analyst to assist with the management and analysis of R&D experimental and clinical trial data as we develop in vitro diagnostic devices for clinical laboratories and clinical decision support software.

The primary focus for this position will be on managing the influx of clinical data to support development activities and regulatory filings, in a collaborative, fast-paced environment in Morrisville, North Carolina.

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 and data transformation.
• Proficiency in regression, ROC curves, hypothesis testing, and sample size calculation.
• Strong written and verbal communication skills.

Responsibilities

• Extract data from laboratory instruments, clinical trial databases, and PHI sources, 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 workflows.
• Compile, analyze, and interpret performance data to support development, verification, validation, and regulatory activities.
• Design and execute statistical analyses, including accuracy, precision, and diagnostic performance studies.
• Support development and validation of machine learning models through data preparation and 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

Statistical analyses

Data visualization

Regulatory knowledge

Communication

Education

MS in Statistics/Biostatistics/Data Science/Bioinformatics

Tools

R

Python

Excel

Word

Job description

Ad Astra Diagnostics (AAD) is seeking a mid-level Clinical Data Analyst to assist with the management and analysis of R&D experimental and clinical trial data as we develop in vitro diagnostic devices for clinical laboratories and clinical decision support software.

The primary focus for this position will be on managing the influx of clinical data to support development activities and regulatory filings, in a collaborative, fast-paced environment in Morrisville, North Carolina.