Clinical Analyst at Spatial Front in Location not listed

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.

• 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
• This 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.