Junior Analyst

Summary

Join TechSilo's team as a Junior Analyst and contribute your expertise to mission-critical projects supporting public health and regulatory science. You will support and enhance the quality and integrity of drug regulatory data by reviewing, extracting, and standardizing information within the FDA's DASH database. This role involves close collaboration with the FDA DASH team to capture, interpret, and analyze regulatory data. The position is primarily remote, with occasional meetings at the FDA White Oak Campus. You will make a concrete impact on drug review process improvements, whether you are experienced in life sciences data analysis or eager to deepen your expertise. This is a fantastic opportunity for those passionate about life sciences, drug regulatory data, and data analysis.

Requirements

• Security Clearance: Eligible for NACI (Public Trust) clearance (required)
• Education: Bachelor’s degree in Life Sciences, Biostatistics, Public Health, Data Science, or related field (required)
• Experience: Minimum of 2 years of professional experience, including experience working with FDA CDER regulatory data, drug review submissions, or biomedical data analysis
• Skills & Certifications: Experience with data standardization and structured formatting procedures
• Proficiency with spreadsheet software (e.g., Microsoft Excel, Google Sheets)
• Experience with Microsoft Access or other structured data entry/database tools
• Experience conducting or supporting data analysis in a regulatory or scientific context
• Familiarity with FDA’s CDER drug review process and regulatory informatics workflows (required); direct experience preferred
• Strong data entry skills with high attention to detail
• Excellent organizational skills and ability to work independently
• Physical Requirements: Ability to work in a remote/flexible environment with standard office equipment

Responsibilities

• Reviewing electronic and paper submissions in accordance with DASH standard operating procedures as part of the FDA CDER drug review process
• Extracting relevant information as identified by FDA experts
• Performing accurate and standardized data entry using a custom-designed DASH database interface
• Collaborating with the FDA DASH team to ensure data consistency and quality
• Participating in quarterly quality assessments to maintain data accuracy and integrity
• Standardizing data formats and terminology to ensure consistency across FDA drug submissions

Preferred Qualifications

• Familiarity with FDA systems, including the Division of Data Management and DASH workflow processes, is a plus
• Experience working with database management tools or custom data entry interfaces
• Familiarity with statistical analysis software (e.g., SAS, R, or Python) is a plus
• Experience with DASH or similar regulatory databases preferred

Benefits

This is primarily remote position, however, may be required to attend occasional meetings at the FDA White Oak Campus in Silver Spring, MD