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Machine Learning Algorithm Consultant

PURE DIAGNOSTICS LLC
Remote

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Job Details

Part-time

Qualifications

AI models
Clinical laboratory experience
Machine intelligence
AI
ISO 13485

Full Job Description

Wren Laboratories is seeking an experienced consultant with expertise in liquid biopsy machine learning (ML) and clinical diagnostic algorithm development to support blood-based transcriptomic molecular diagnostics utilization.

The ideal candidate will have experience developing, verifying, validating, and documenting ML-based clinical classification algorithms, including:

· Development and validation of clinical classification algorithms for molecular diagnostics, liquid biopsy, genomics, transcriptomics, or precision medicine applications

· Design and management of training, testing, and independent validation datasets

· Binary and multi-class predictive modeling

· Clinical cutoff determination and optimization

· Performance assessment (sensitivity, specificity, PPV, NPV, ROC/AUC, etc.)

· Analytical and clinical validation studies

· FDA, CLIA, CAP, ISO 13485, SaMD, AI/ML, De Novo, 510(k), or PMA documentation and regulatory submissions

· Algorithm governance, version control, change management, and lifecycle management

Experience in diagnostics, molecular testing, genomics/transcriptomics, laboratory medicine, or regulated healthcare environments is strongly preferred.

Engagement will be project/task-based, with compensation commensurate with predefined scope, complexity, and data volume.

If interested, please send a brief summary of your experience and relevant projects via LinkedIn message or email to [email protected].

Work Location: Remote

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