Clinical Analyst

Spatial Front, Inc; Washington (District of Columbia); On-site; USD 90,000 - 130,000; Full time

Job summary

Spatial Front, Inc. seeks a Clinical Analyst to provide scientific and clinical analytical support to regulatory review teams. You will evaluate drug data, review safety information, and prepare reports to support risk determinations in FDA contexts.

The role requires deep health and data science knowledge, with experience in SDTM/ADaM, and the ability to produce clear, regulatory-ready documents. This is a full-time on-site position in the Washington, DC area.

Qualifications

• PhD or PharmD is required.
• 5+ years in a similar clinical or regulatory role.
• Expert level R programming skills.
• Ability to synthesize clinical safety data to inform risk assessments.
• Experience with SDTM/ADaM data standards in clinical trials.
• Proven track record producing scientific reports and documents.

Responsibilities

• Analyze and evaluate submitted drug data and prepare analytical summaries of safety data.
• Review NDAs/BLAs and amendments; draft reports and recommendations for FDA review.
• Incorporate safety data reviews into integrated assessments.
• Support labeling reviews with safety data analyses for labeling accuracy.
• Draft scientifically sound reports and communications for FDA teams.
• Review literature and maintain awareness of developments in relevant therapeutic areas.
• Support meetings with sponsors, advisory committees, and external bodies.

Skills

R Programming

CDISC SDTM/ADaM

Biostatistics

Machine learning

Epidemiology

Clinical safety data analysis

Education

PhD/PharmD

Job description

Description

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.

Requirements

• PhD/PharmD required
• 5+ years of experience in a similar role
• Expert level R Programming skills required
• Experience in applying clinical safety data analytical skills, including the ability to synthesize clinical and scientific evidence to inform risk assessments
• Experience with CDISC data standards (including SDTM and ADaM) and their application in the organization and analysis of clinical trial datasets.
• Experience producing a variety of written scientific reports and documents

Desired Skills

• Familiarity with FDA regulations, policies, and procedures pertaining to safe drugs and biologics, including NDA, and BLA review processes
• Statistical background, including experience with biostatistical methods commonly applied in clinical trial design, analysis, and interpretation (e.g., survival analysis, mixed-effects models, hypothesis testing).
• Machine learning and AI background, including familiarity with predictive modeling techniques
• Epidemiological background, including experience with observational study design, real-world evidence, pharmacoepidemiology, or population-level safety surveillance methods

Additional Information

• In order to meet the clearance requirements for this opportunity, candidates must be US Citizen and/or Current Green Card Holder.
• All candidates will be subject to a complete background check to include, but not limited to Criminal History, Education Verification, Professional Certification Verification, Verification of Previous Employment and Credit History.
• Public Trust background investigations can take approximately four to eight weeks and requires fingerprinting.

Other Information

• The salary for this position is $90,000 - $130,000 annually
• For information on SFI's benefits please visit http://www.spatialfront.com/pages/career.html
• These is a full-time W2 position.
• Please no agencies, third parties, or corp-to-corp.
• Spatial Front Inc. is an Equal-opportunity Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• Spatial Front Inc. participates in E-Verify.

Salary Description

$90,000 - $130,000 Annually