Clinical Data Analyst/Biostatistician

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 (AAD) is seeking a mid-level Clinical Data Analyst to assist with the management and analysis of R&D experimental and clinical research 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.

Job Duties/responsibilities:

• Extract data from laboratory instruments, clinical trial databases, and internal and 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.

Job Requirements:

• M.S. 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

Preferred Qualifications:

• Familiarity with CLSI standards (EP05, EP09, EP12, EP21, etc.)
• Experience supporting FDA 510(k), De Novo, or PMA submissions.
• Experience with in vitro diagnostic devices and clinical laboratory data.
• Experience supporting Software as a Medical Device (SaMD) or Clinical Decision Support products.
• Experience with ETL workflows

What We Offer

• Salary range for this role is $95,000-115,00
• Competitive benefits, including health, dental, and vision insurance, 401k, paid vacation, life AD&D insurance and short-term and long-term disability benefits

About AAD

At AAD, we are committed to our team and customers. We believe in fostering a culture that promotes creativity, learning, and leadership. Through our efforts and values, AAD has been able to cultivate new ideas and create new technologies to revolutionize the healthcare industry.
We welcome enthusiastic, driven professionals, passionate about positively impacting healthcare by providing relevant, valuable, and actionable information. We are devoted to creating a diverse and inclusive environment in order to best support innovation and the talents of our people. We look for people who bring diverse ideas, demonstrate integrity and show dedication to the success of our customers.