Senior Software Engineer II: AI-Driven Regulated Trials

Formation Bio; New York (NY); Hybrid; USD 214,000 - 267,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Hybrid work model

Job summary

Formation Bio is hiring a Senior Software Engineer II to own a meaningful slice of the Trial Execution platform. You will drive integrations with EDC and clinical systems, ensure validated SDLC practices, and build AI-native capabilities with robust provenance and audit trails.

You’ll work across Clinical Operations, Data Management, Regulatory, QA, Data Engineering, and Infrastructure to ship and operate production software for active trials in a regulated context.

Qualifications

• 7+ years of experience building production software in a clinical trial context.

Responsibilities

• Drive design, delivery, and operation of production software used in live clinical trials, from site startup and activation through data collection, monitoring, and close-out.

Skills

Production software

Regulated software

Cloud fundamentals

AI tools

Clean code

Distributed systems

Communication

Adaptability

Tools

AWS

GCP

Azure

Job description

Formation Bio is hiring a Senior Software Engineer II to own a meaningful slice of the Trial Execution platform. You will drive integrations with EDC and clinical systems, ensure validated SDLC practices, and build AI-native capabilities with robust provenance and audit trails.

You’ll work across Clinical Operations, Data Management, Regulatory, QA, Data Engineering, and Infrastructure to ship and operate production software for active trials in a regulated context.