Clinical Data Analyst/Biostatistician

Ad Astra Diagnostics•Morrisville, NC

About The Position

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.

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

Nice To Haves

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

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.