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 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 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 vision a reality.
Project Description : Our client 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.
Job Summary : DRT is looking for a Principle Systems Architect (Data Scientist) with a PhD or PharmD degree and strong R programming skills for data analysis. The ideal candidate will possess a deep understanding of clinical data structures, trial design, and analytical methods, including CDISC format. Key responsibilities involve developing and executing safety data review plans (SDRPs), performing comprehensive safety analyses, and providing detailed written reports and presentations to clinical review teams. This position requires an individual who can proactively identify and solve problems related to workflows and data quality, and who can serve as a subject matter expert in meetings with stakeholders. The role demands excellent communication skills, a team-oriented attitude, and the ability to verify safety data for proposed drug labels and marketing applications.
Responsibilities
Experience & Education
EEO & Compliance
DRT Strategies, Inc. follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex, national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law. Reasonable accommodations for applicants and employees with disabilities will be provided. For accommodation requests, contact Human Resources at HR@drtstrategies.com.
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Principal Architect • Silver Spring, MD, United States