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 your vision a reality. Project Description This project will support the Office of New Drugs within FDA’s Center for Drug Evaluation and Research (CDER). Specifically, this project will support OND’s Integrated Review for Drug Marketing Applications program by providing comprehensive safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers. Job Summary The Clinical Data Scientist 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 reviewing safety data sufficiency and integrity, conducting safety data analyses, verifying safety data submitted by the applicant, and generating high-quality scientific reports. Responsibilities + Prepare, oversee, and maintain project schedules. + Develop safety data review plans (SDRPs) with clinical reviewers in advance of initial scoping meetings. + Execute SDRPs in support of marketing application review process. + Provide written reports regarding assessment of safety data sufficiency, integrity, and quality to clinical review teams. + Perform comprehensive safety data analyses and 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 submitted by the applicant in the proposed drug label, clinical study report, and integrated summary of safety. + Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses. + Collaborate with CDER OND staff to optimize team processes and deliverables. + Work with FDA stakeholders to review background packages and mock safety datasets to assess appropriateness of controlled terminology and safety dataset structure. + Interact with government and contractor teams to help manage and monitor project progress, risk, issues, and track action items. + Manage, organize, and update SharePoint sites. + Assist in overall project support, as needed Required Experience + Minimum of 3 years professional experience. + Technical proficiency in programming languages- R (mandatory). + R programming – ability to troubleshoot errors in R. + Experience with CDISC format and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt) + Understands data analytical methods (e.g., longitudinal analysis, time-to-event analyses, and causal/correlation analyses) for conducting safety data analyses (tables and figures) + Understands safety review elements including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs. + Strong analytical and statistical skills to assess safety data. + Excellent organizational, time management, verbal and written communication skills. + Ability to independently manage a variety of projects with frequent interruptions and shifting priorities. + Ability 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 within a multidisciplinary team. Preferred Experience + Proficiency to manipulate data using R programming. + Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc. + Experience on SAS programming. + Understands general concept of clinical trial design and drug development (e.g., adequate and well-controlled studies) + Familiarity with FDA regulatory process. + Working experience at FDA. + Experience in clinical trials, especially statistical hypothesis testing methods. + Managerial experience- leading and mentoring a team. Education and Training + PharmD or PhD in the STEM disciplines: bioinformatics, Public Health, Pharmacology, Toxicology, Biology, Biomedical Engineer, biology, biostatistics, epidemiology, health informatics, or pharmaceutical science. DRT’s culture is reflective of our core values: + Professionalism:  Be a leader and someone your customers and colleagues can count on by taking ownership and accountability for your work. Demonstrate a solution-oriented mindset and bias for action. Show empathy, dignity, and respect for each other. Be "high minded", maintain a calm demeanor when dealing with ambiguity or adversity and stay out of the fray (i.e., avoid drama). + Quality:  Do things right and do the right thing. Pursue excellence in your work by delivering quality services and products that provide high value and return on investment (ROI). + Teamwork:  Work with each other, the customer, and DRT. Demonstrate flexibility, a positive attitude and willingness to work collaboratively to help others and share information. + Customer Mission Focused: Commit to customer success and strive to exceed expectations by understanding the mission, executing the customer's vision, and solving challenges to drive results and achieve mission goals. Build meaningful customer relationships by asking thoughtful questions, listening, and operating transparently. + Growth Mindedness:  Commit to company, team, and personal growth. Embrace an entrepreneurial spirit by actively seeking opportunities to support new customer projects and/or solve problems. Actively work to improve your skills, learn to be comfortable with ambiguity, and be resourceful and willing to figure things out and add value. Our culture fosters teamwork and transparency, empowering you to do great work. Our talented employees drive the success of the company – so our leadership is devoted to your success.  We respect you as an individual.  We recognize your contributions.  We invest in your professional growth.  Join us and let's continue to build your career together. Currently due to the remote working status of the federal government, most DRT employees are teleworking from home and leveraging video conferencing along with other virtual productivity tools. Under normal circumstances, most of our positions are required to report onsite. However, DRT has not yet determined when employees will be required to return to their onsite workspaces. Please be aware that at the time a date is determined to return to the worksite, the requirement of this position may be to report in person to the work location. 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.   DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and qualified applicants for employment without regard to race, color, creed, religion, national origin, gender, sexual orientation, age, gender identity, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local laws. Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517. Powered by JazzHR