Spatial Front provides IT solutions to federal, state, and local governments and the private sector.  We are looking for a Clinical Data Scientist to support our federal government customer.  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 guides 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 that will 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.

• A successful candidate is required to fulfill the below to be considered:
  • Have a Ph.D. (in pharmaceutical sciences, pharmacology, data science, informatics, public health, or epidemiology-related fields) or a PharmD degree.
  • Possesses strong R programming skills in data analysis and a deep understanding of clinical data structure, clinical trial design, and safety data analytical methods.
  • Have demonstrated experience with CDISC format and safety dataset structure (adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt).
  • Understand data analytical methods (time-to-event analyses, causal/correlation analyses, longitudinal analyses, etc.) for conducting safety data analyses (tables and figures).
  • Understand safety review elements (including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs).
  • Possess excellent written and oral communication skills.
  • Demonstrate a forward-thinking, team-oriented attitude.
  • Prepare, maintain, and perform quality control/oversight of project schedules.
  • Evaluate analytically and systematically problems of workflows, organization, and planning and develop appropriate corrective action.
  • Develop safety data review plans (SDRPs) with clinical reviews before initial scoping meetings.
  • Execute SDRPs in support of the marketing application review process.
  • Develop and submit written reports covering the assessment of safety data sufficiency, integrity, and quality to clinical review teams.
  • Perform comprehensive safety data analyses; provide written reports containing standardized safety tables and figures to clinical review teams.
  • Conduct in-depth safety analyses for specific safety signals (as requested by clinical review teams).
  • Verify safety data in the proposed drug label, clinical study report, and integrated summary of safety.
  • Lead meetings with clinical and statistical reviewers; present results from data quality assessments and standard safety data analyses.
  • Meet with CDER OND staff as needed.
  • Work with stakeholders to review background packages and mock safety data sets to assess the appropriateness of controlled terminology and safety dataset structure.

• 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.

Desired Skills & Qualifications:

• R Programming
• Ph.D. (in pharmaceutical sciences, pharmacology, data science, informatics, public health, or epidemiology-related fields) or PharmD

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.

 

Apply here