Non-Clinical Data SME

Qualifications

Required:

• Bachelor’s degree or higher in Toxicology, Pharmacology, Biology, Veterinary Science, Statistics, Bioinformatics, Data Science, or a related scientific/technical field; advanced degree preferred.
• Approximately 8+ years of nonclinical research, pharmaceutical, regulatory, or scientific-data experience.
• At least 5 years of substantive experience with CDISC SEND or comparable depth of SEND implementation expertise.
• Expert knowledge of SEND datasets and SEND Implementation Guides.
• Strong understanding of nonclinical/toxicology study data and regulatory submission structures.
• Experience evaluating SEND data quality, conformance, usability, and standards implementation.
• Experience with SAS, R, JMP, or comparable scientific/statistical analytical tools.
• Ability to interpret complex nonclinical datasets and communicate findings to scientific reviewers.
• Demonstrated experience developing technical documentation, analytical specifications, training materials, or standards guidance.
• Strong presentation and stakeholder-support skills.

Skills

Highly Desired:

• Previous FDA/CDER nonclinical review or FDA contractor experience.
• Hands-on experience with SEND Explorer / SEND Explorer Warehouse or comparable SEND visualization/review tools.
• Experience supporting FDA DataFit or submission-data assessment activities.
• Knowledge of emerging SEND standards and implementation guides.
• Experience conducting SEND standards pilots or evaluating standards changes.
• Familiarity with CDISC controlled terminology and data-standard governance.
• Experience providing technical training, office hours, demonstrations, or direct reviewer support.