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OverviewDRT 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 OverviewThis 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) and Safety Data Analyses.Job OverviewThe 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
3-5 years of experience working with physicians and/or clinician scientists. Technical proficiency in programming languages, Python and R
Strong analytical and statistical skills to assess safety data
508 Compliance: must meet WCAG 2.0 A and AA
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
Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, SAS, etc.
Familiarity with FDA regulatory process
Experience in clinical trials, especially statistical hypothesis testing methods
Education and Training
PhD in the STEM disciplines: data science, bioinformatics, public health, pharmacology, biology, biostatistics, computer science, epidemiology, or health informatics
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.
