Clinical Analyst

Spatial Front, Inc. (SFI), a two-time USAToday Top Workplaces awardee and Washington Top Workplaces honoree, is seeking a Clinical Analyst to support our growing team. This position provides scientific and clinical analytical support to our client's multi-disciplinary review teams. The chosen candidate will assist in the evaluation of drug applications, review clinical safety data, labeling assessment, and preparation of scientific reports. The work requires advanced knowledge in health and data sciences and the ability to apply scientific expertise to support risk determinations in the context of regulatory review.

Primary Responsibilities:

Clinical Data Analysis and Review

• Analyze and evaluate submitted data from applicants seeking permission to market new drugs for general use and prepare analytical summaries on the adequacy of safety data provided.
• Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration.
• Incorporate summaries from clinical safety data reviews as part of integrated multi-disciplinary assessments.

Labeling Review Support

• Assist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported.
• Provide draft safety data analyses on labeling accuracy and completeness for review by FDA staff.

Scientific Correspondence and Reporting

• Draft scientifically sufficient reports of findings that clearly communicate clinical safety analyses and conclusions.
• Prepare draft correspondence identifying facts and information inadequately presented in sponsor submissions, for FDA reviewer finalization and issuance.
• Prepare clear summaries of clinical safety data tables, figures and listings for FDA review team use.

Literature Review and Knowledge Management

• Review scientific literature and maintain awareness of current clinical developments and evolving findings in relevant therapeutic areas.
• Support preparation of background materials for seminars, conferences, and industry meetings.

Stakeholder Support

• Support clinical review teams in preparing for meetings with drug company representatives, advisory committees, and external scientific bodies.