Clinical Analyst

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Spatial Front, Inc

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🤝 B2B

🏢 Enterprise

☁️ SaaS

B2B • Enterprise • SaaS

Spatial Front, Inc. is an industry leader in delivering cutting-edge technical solutions and mission support services, dedicated to advancing businesses into the 21st century. Founded in 2008 and headquartered in Bethesda, MD, with offices in McLean, VA and Oklahoma City, OK, the company has been recognized as an Inc 5000 Honoree for five consecutive years. Spatial Front is a woman-owned, SBA 8(a) certified small business with numerous certifications, including CMMI-DEV Level 3 and ISO 27001. The company partners with leading technology firms like Amazon AWS and Microsoft, and specializes in areas such as DevOps, AI, cloud computing, and more, offering tailored solutions in system engineering, big data, and emerging technologies.

📋 Description

• Analyze and evaluate submitted applicant data for new drug marketing applications and prepare analytical summaries of safety-data adequacy • Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration • Incorporate clinical safety-data review summaries into integrated multidisciplinary assessments • Assist with proposed drug-labeling review to assess whether safety claims are truthful and adequately supported • Provide draft safety-data analyses on labeling accuracy and completeness for FDA staff review • Draft scientifically sufficient reports communicating clinical safety analyses and conclusions • Prepare draft correspondence identifying inadequately presented facts and information in sponsor submissions • Prepare clear summaries of clinical safety-data tables, figures, and listings for FDA review teams • Review scientific literature and maintain awareness of current clinical developments and findings • Support preparation of background materials for seminars, conferences, and industry meetings • Support clinical review teams preparing for meetings with drug company representatives, advisory committees, and external scientific bodies

🎯 Requirements

• PhD/PharmD required • 5+ years of experience in a similar role • Expert-level R programming skills required • Experience applying clinical safety-data analytical skills and synthesizing clinical and scientific evidence for risk assessments • Experience with CDISC data standards, including SDTM and ADaM, and their application to organizing and analyzing clinical-trial datasets • Experience producing written scientific reports and documents • Familiarity with FDA regulations, policies, and procedures for safe drugs and biologics, including NDA and BLA review processes • Statistical background, including biostatistical methods used in clinical-trial design, analysis, and interpretation, such as survival analysis, mixed-effects models, and hypothesis testing • Machine learning and AI background, including familiarity with predictive modeling techniques • Epidemiological background, including observational study design, real-world evidence, pharmacoepidemiology, or population-level safety-surveillance methods • Must be a US Citizen and/or Current Green Card Holder • Must pass a complete background check, including criminal history, education verification, professional certification verification, previous-employment verification, and credit history • Public Trust background investigation requiring fingerprinting

🏖️ Benefits

• Full-time W2 position • Equal-opportunity employment • E-Verify participation • Public Trust background investigation support, including fingerprinting