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. You will make a concrete impact on drug review process improvements. The position requires a Bachelor's degree in a related field and at least two years of professional experience working with FDA CDER regulatory data. A security clearance is also required.

Requirements

• Be eligible for NACI (Public Trust) clearance
• Have a Bachelor’s degree in Life Sciences, Biostatistics, Public Health, Data Science, or related field
• Have minimum of 2 years of professional experience, including experience working with FDA CDER regulatory data, drug review submissions, or biomedical data analysis
• Have experience with data standardization and structured formatting procedures
• Be proficient with spreadsheet software (e.g., Microsoft Excel, Google Sheets)
• Have experience with Microsoft Access or other structured data entry/database tools
• Have experience conducting or supporting data analysis in a regulatory or scientific context
• Have familiarity with FDA’s CDER drug review process and regulatory informatics workflows

Responsibilities

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

Preferred Qualifications

• Have experience working with database management tools or custom data entry interfaces
• Have familiarity with statistical analysis software (e.g., SAS, R, or Python)
• Have experience with DASH or similar regulatory databases
• Have strong data entry skills with high attention to detail
• Have excellent organizational skills and ability to work independently
• Have the ability to work in a remote/flexible environment with standard office equipment