Senior Scientist, Safety Analytics & Toxicology

BioSpace

Indianapolis (IN)

On-site

USD 66,000 - 189,000

Full time

4 days ago
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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Medical, dental, vision

Job summary

Lilly in Indianapolis is seeking a Senior Scientist for the Safety Assessment team to lead data-driven toxicology analyses and cross‑functional collaboration across CMC, DMPK, and Project Management.

This 100% non-laboratory role focuses on data modeling, SEND data auditing, mechanistic syntheses, and governance, delivering publication-ready dashboards and critical safety memos to inform regulatory strategies.

Qualifications

  • MS or BS with substantial biotech/pharma/toxicity operations experience.
  • BS with 8–10+ years in industrial drug development and data management.
  • Expert-level understanding of preclinical toxicology datasets and study designs.
  • Hands-on auditing/validation of regulatory SEND data structures.
  • Strong technical writing and cross-functional influence skills.

Responsibilities

  • Architect data models to transform multi-dose toxicology data into publication-ready visuals.
  • Oversee SEND data review for CROs, ensuring compliance and alignment with reports.
  • Synthesize literature to assess safety risks and inform toxicity strategies.
  • Co-author data packages, briefing books, and executive slides.
  • Collaborate with Safety Assessment, CMC, DMPK, and Project Management to meet milestones.

Skills

Data Visualization
Toxicology Data
Regulatory SEND
Technical Writing
Leadership

Education

MS in Toxicology or related
BS in Life Sciences

Tools

GraphPad Prism
Spotfire
Excel macros
Python/R

Job description

Lilly in Indianapolis is seeking a Senior Scientist for the Safety Assessment team to lead data-driven toxicology analyses and cross‑functional collaboration across CMC, DMPK, and Project Management.

This 100% non-laboratory role focuses on data modeling, SEND data auditing, mechanistic syntheses, and governance, delivering publication-ready dashboards and critical safety memos to inform regulatory strategies.

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