Junior Analyst- Remote
Junior Analyst- Remote
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Salary Not Disclosed
1 Vacancy
Job Description
Are you ready to contribute your expertise to mission-critical projects supporting public health and regulatory science TechSilo is looking for a Junior Analyst to support and enhance the quality and integrity of drug regulatory data by reviewing extracting and standardizing information. This opportunity supports the Data Analysis Search Host (DASH) database developed by the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA). If youre passionate about life sciences drug regulatory data and data analysis and meet the qualifications below this could be the perfect role for you.
In this position youll work closely with the FDA DASH team to capture interpret and analyze regulatory data that supports advancements in regulatory science. Whether youre experienced in life sciences data analysis or eager to deepen your expertise youll be making a concrete impact on drug review process improvements. This is primarily remote position however may be required to attend occasional meetings at the FDA White Oak Campus in Silver Spring MD.
On a given day you will spend time:
- 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
Qualifications :
- Security Clearance: Eligible for NACI (Public Trust) clearance (required)
- Education: Bachelors 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 FDAs CDER drug review process and regulatory informatics workflows (required); direct experience preferred
- 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
- 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
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
