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Senior Clinical Data Analyst

Company: DRT Strategies, Inc.
Location: Silver Spring
Posted on: August 15, 2019

Job Description:

Overview

DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and the financial services industries.

The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing IT challenges - together.

We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make your vision a reality.

Project Overview

This project will support the FDA's Center for Drug Evaluation and Research (CDER), in particular the Office of New Drugs (OND). Specifically, this project will support OND's user fee documentations and reviews by providing technical support to Safety Data Analysis Plan (SDAP).

Job Overview

The clinical data analyst position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers. This role will be responsible for the reviewing of clinical data sufficiency and integrity, verifying clinical safety data, and conducting standardized clinical safety analyses. The clinical data analyst will work closely with medical editors on the marketing application review and provide ad-hoc support, as needed.

Responsibilities


  • Work with FDA stakeholders to review background packages and mock safety datasets to assess appropriateness of controlled terminology and safety dataset structure
  • Develop SDAPs with clinical reviewers in advance of initial scoping meetings. Execute SDAPs in support of marketing application review process
  • Provide written reports regarding assessment of safety data sufficiency, integrity, and quality to clinical review teams
  • Conduct preliminary safety assessments and provide written reports to clinical review teams
  • Perform comprehensive safety data analyses and provide written reports containing standardized safety tables and figures to clinical review teams. Create additional safety tables and figures based on requests of clinical review teams
  • Manage, organize, and update SharePoint sites
  • Assist in overall project support, as needed

    Required Experience

    • Masters (with 5+ years of relevant experience) or PhD (with 2+ years of relevant experience) in the STEM disciplines: bioinformatics, biology, biostatistics, computer science, epidemiology, or health informatics
    • Technical proficiency in programming languages, Python and R
    • Strong analytical and statistical skills to assess safety data
    • Excellent organizational, time management, and communication skills
    • Ability to independently manage a variety of projects with frequent interruptions and shifting priorities to organize a continuous flow of work in a timely manner and meet mandatory deadlines
    • Computer skills: MS Office Suite (particularly PowerPoint, Word, Excel), Adobe Acrobat
    • Ability to work independently and within a multidisciplinary team

      Preferred Experience

      • Advanced Degree or Certifications
      • Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc.
      • Familiarity with FDA regulatory process
      • Experience in clinical trials, especially statistical hypothesis testing methods
      • Managerial experience - leading and mentoring a team.

        Education and Training

        • Masters Degree or PhD in STEM or relevant field required

          DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetics, disability, or protected veteran status. In addition to federal law requirements, DRT complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.

Keywords: DRT Strategies, Inc., Silver Spring , Senior Clinical Data Analyst, Healthcare , Silver Spring, Maryland

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