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AI Clinical Trial Signal Detection Analyst

James Yamamoto

Full-time · Job · New_York

About the role

Adverse drug reactions kill 100,000 people per year in the US alone. Detecting safety signals early in clinical trials — before a drug reaches market — saves lives but requires sifting through millions of adverse event reports to find patterns that aren't obvious in individual cases. Our signal detection platform identifies emerging safety concerns from trial data weeks before traditional pharmacovigilance methods. You'll build the statistical models that scan adverse event databases for disproportionate reporting: Bayesian shrinkage estimators for rare events, temporal pattern detection for delayed-onset reactions, and multi-source signal fusion that combines trial data with post-market surveillance. Each detected signal triggers an automated assessment pipeline that quantifies confidence and clinical significance. The pharmacovigilance AI team is five people. You'll work alongside a clinical pharmacologist who validates detected signals against medical knowledge and regulatory pharmacovigilance officers who define what constitutes a reportable signal.

Responsibilities

  • Build statistical signal detection models for adverse event databases
  • Implement Bayesian disproportionality analysis for rare event detection
  • Design temporal pattern detection for delayed-onset adverse reactions
  • Create automated signal assessment pipelines quantifying confidence
  • Validate detected signals against clinical pharmacology expertise
  • Support regulatory reporting workflows with signal documentation

Requirements

  • 3+ years in biostatistics, pharmacovigilance, or clinical data science
  • Experience with disproportionality analysis or signal detection methods
  • Strong Python and statistical modeling skills
  • Understanding of adverse event reporting systems and MedDRA coding
  • Ability to communicate statistical findings to clinical audiences

Benefits

  • Fully remote with quarterly team meetings
  • Health, dental, and vision insurance
  • $3,500 annual conference and learning budget
  • 401(k) with employer match
  • Work that directly improves patient safety

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Job Type

Full-time

Level

Mid-Level

Language

English

Salary Range

$100k – $130k / year

AI Expertise

data science & analytics AI & Machine Learning Engineers

Skills

python pytorch sql statistics pandas docker

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