Description

The U.S Food and Drug Administration Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. 

To accomplish its mission, CDER OND follows a process for drug reviews called the CDER 21st Century Review Process, which includes specific reviewer activities and timelines for the completion of various review milestones. In this project, CDER OND aims to achieve analytical and safety planning and reporting to enable reviewers to execute OND’s mission. Reviewers will support OND’s Integrated Review for New Drug Marketing Applications program by conducting comprehensive safety data quality assessments and safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers. 

Primary Responsibilities:

• Candidates must have a Ph.D. (in pharmaceutical sciences, pharmacology, data science, informatics, public health, or epidemiology-related fields) or a Pharm.D. degree to be considered.
• Candidates must possess strong R programming skills in data analysis and a deep understanding of clinical data structure, clinical trial design, and safety data analytical methods.
• Candidates must have excellent written and oral communication skills.
• Establish system information requirements using analysis of the information engineer(s) in the development of enterprise-wide or large-scale information systems.
• Evaluate analytically and systematically problems of workflows, organization, and planning and develop appropriate corrective action.
• Excellent communication skills
• Task areas include but are not limited to:
  • Administrative and Managerial Support
  • Investment and Capital Planning
  • Baseline Program & Project Management
  • Transition In & Out
  • Strategic Development & Collaboration
  • Governance & Documentation
  • Controlled Unclassified Information
  • Digitization, Modernization & Migration
  • Program Operational Support
• Meet with CDER OND staff as needed
• Experience working in an Agile workflow environment
• Experience with enhancing and modernizing legacy systems
• Coding experience is a must
• Ability to work with FDA stakeholders to demo and discuss upcoming enhancements and platform changes

Requirements

• Minimum of Ph.D. in a related field or PharmD.
• 8-10 years of experience is preferred, but the client is willing to waive the requirement if the candidate is a Ph.D. with strong R programming skills.

Additional Information:

• To meet the clearance requirements for this opportunity, candidates must be authorized to work in the US.
• All candidates will be subject to a complete background check to include, but are 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 require fingerprinting.

Other Information:

• The salary for this position is $80,000 - $140,000 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.