Regulatory Clinical Data Analyst — Drug Safety & FDA Focus

Spatial Front, Inc; Washington (District of Columbia); On-site; USD 90,000 - 130,000; Full time

Job summary

Spatial Front, Inc. seeks a Clinical Analyst to provide scientific and clinical analytical support to regulatory review teams. You will evaluate drug data, review safety information, and prepare reports to support risk determinations in FDA contexts.

The role requires deep health and data science knowledge, with experience in SDTM/ADaM, and the ability to produce clear, regulatory-ready documents. This is a full-time on-site position in the Washington, DC area.

Qualifications

• PhD or PharmD is required.
• 5+ years in a similar clinical or regulatory role.
• Expert level R programming skills.
• Ability to synthesize clinical safety data to inform risk assessments.
• Experience with SDTM/ADaM data standards in clinical trials.
• Proven track record producing scientific reports and documents.

Responsibilities

• Analyze and evaluate submitted drug data and prepare analytical summaries of safety data.
• Review NDAs/BLAs and amendments; draft reports and recommendations for FDA review.
• Incorporate safety data reviews into integrated assessments.
• Support labeling reviews with safety data analyses for labeling accuracy.
• Draft scientifically sound reports and communications for FDA teams.
• Review literature and maintain awareness of developments in relevant therapeutic areas.
• Support meetings with sponsors, advisory committees, and external bodies.

Skills

R Programming

CDISC SDTM/ADaM

Biostatistics

Machine learning

Epidemiology

Clinical safety data analysis

Education

PhD/PharmD

Job description

Spatial Front, Inc. seeks a Clinical Analyst to provide scientific and clinical analytical support to regulatory review teams. You will evaluate drug data, review safety information, and prepare reports to support risk determinations in FDA contexts.

The role requires deep health and data science knowledge, with experience in SDTM/ADaM, and the ability to produce clear, regulatory-ready documents. This is a full-time on-site position in the Washington, DC area.