Aptive seeks an experienced Senior Analyst to support the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). The Senior Analyst will work closely with principal investigators, program managers, and FDA leadership and researchers to provide advanced analytical, clinical research management, and strategic support for applied research and administrative processes. 

The ideal candidate has FDA CDER expertise and is familiar with their administrative and clinical research activities. They have previous clinical research experience and are highly organized and systematic in their project work. They exceed client expectations with high-quality work in a fast-paced environment.

• 10+ years of relevant experience in program evaluation, regulatory analysis, or scientific research support.
• Bachelor’s degree (Master’s preferred) in Public Health, Policy, Science, Data Analytics or other related field.
• Demonstrated experience drafting technical documents and research materials for federal agencies or healthcare programs.
• Proficiency with Microsoft Office Suite, SharePoint, Power Automate, PowerBI and EndNote (or similar).
• Familiarity with FDA regulatory processes and clinical research lifecycles.
• Must meet U.S. residency requirement (3 of last 5 years) and be eligible for Public Trust clearance.

• Proven ability to support large, cross-functional teams while maintaining excellent written and verbal communication with diverse stakeholders.
• Experience managing end-to-end lifecycle of regulatory science and clinical research projects, including developing budget estimates.
• Ability to draft, edit and format scientific documentation, such as concept papers, study protocols, informed consents, statistical analysis plans, and final reports.
• Experience providing technical writing support for manuscripts and journal submissions, including literature reviews and reference management.
• Experience using SharePoint and Power Platforms (e.g., Power Automate and Power BI) to track, automate, and analyze workflows to ensure process optimization and high-quality execution of research tasks.
• Able to conduct landscape and feasibility assessments and produce reports summarizing key findings and strategic opportunities.
• Experience leading and mentoring analysts in the execution of day-to-day research tasks.
• Strong interpersonal and written communications skills; comfort working with technical and non-technical stakeholders.

Aptive is a management consulting firm based in Alexandria, Virginia. With more than 500 employees across the U.S., we primarily support the federal government – more than a dozen agencies like Veterans Affairs, Transportation, Defense, Library of Commerce, Customs and Border Protection and the National Science Foundation. Our work focuses on applying creativity, technology and human-centered services to improve performance, bridge divides and elevate the lives of millions of people who count on government. services every day. 

Aptive is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, color, national origin, religion, creed, sex, sexual orientation, gender identity, marital status, parental status, veteran status, age, disability, or any other protected class.

Veterans, members of the Reserve and National Guard, and transitioning active-duty service members are highly encouraged to apply.