Data Science Specialist for FDA Review

1 week ago


Silver Spring, Maryland, United States DRT Strategies, Inc. Full time

Company Overview

DRT Strategies, Inc. is a leading provider of management consulting and information technology solutions to large federal agencies, the U.S. Navy, state and local government, and commercial clients in the health care, technology, and financial services industries.

We pride ourselves on our ability to drive resolution together with our clients, collaborating to solve their most pressing challenges. Our team of experts combines Fortune 500 experience with small business responsiveness, delivering world-class consulting services that lead to meaningful results.

Job Summary

The Clinical Data Scientist position at DRT Strategies, Inc. involves working closely with FDA stakeholders across various offices and centers, particularly with clinical reviewers (Medical Officers) and statistical reviewers. This role requires reviewing safety data sufficiency and integrity, conducting comprehensive safety data analyses, verifying safety data submitted by applicants, and generating high-quality scientific reports.

Responsibilities

  • Project Management: Prepare, oversee, and maintain project schedules to ensure timely completion of tasks.
  • Safety Data Review: Develop safety data review plans (SDRPs) with clinical reviewers in advance of initial scoping meetings.
  • Data Analysis: Execute SDRPs in support of marketing application review processes, providing written reports regarding assessment of safety data sufficiency, integrity, and quality to clinical review teams.
  • Reporting: Perform comprehensive safety data analyses and provide written reports containing standardized safety tables and figures to clinical review teams.
  • Collaboration: Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses.
  • Communication: Collaborate with CDER OND staff to optimize team processes and deliverables, ensuring seamless communication throughout the project.
  • Technical Skills: Utilize R programming language to troubleshoot errors and perform data manipulation, as well as experience with CDISC format and safety dataset structure.
  • Educational Requirements: A minimum of 3 years of professional experience, preferably in a related field such as pharmacology, toxicology, or epidemiology, with a strong background in data analysis and interpretation.

Compensation and Benefits

As a valued member of our team, you can expect a competitive salary of approximately $120,000 per year, commensurate with your experience and qualifications. Additionally, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.



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