Brillient Corporation
Data Scientist
Silver Spring, MD | $96K - $162K
Qualifications
- This position requires U.S. Citizenship or a permanent resident and the ability to obtain and maintain a Government public trust level security clearance
- Candidates must have lived in the United States for at least three out of the past five years prior to your application date
- You will also meet the residency qualifications if you lived abroad while on government or military duty or if you were a dependent of a federal employee of military member
- The employee should have significant expertise in data science
Responsibilities
- Reviews and evaluate clinical study protocols and reports submitted in NDAs (New Drug Applications), supplemental NDAs, new INDs (Investigational New Drug), new protocols and protocol amendments, and Emergency INDs
- The Data Scientist is responsible for reaching regulatory decisions and recommending approval of safe and effective human drugs
- Evaluates development plans and study protocols to determine if they are safe and if the design is likely to generate evidence of effectiveness
- During these evaluations, the incumbent provides advice to pharmaceutical sponsors and investigators on the design of clinical studies
- For NDAs, the Data Scientist reviews and evaluates reports of clinical trials to determine if the data are adequate and well-controlled, and sufficient to support the efficacy and safety of the drug under investigation
- Ultimately, the Data Scientist recommends approval or disapproval of the application, in conjunction with, and countersigned by, the Medical Team Leader
- The Data Scientist reviews submissions in support of revisions to labeling of approved NDAs
- The Data Scientist with input from other scientific discipline reviewers, reviews these data to determine if the data are sufficient to justify changes in the labeling
- The Data Scientist compiles data to prepare special reports related to the work of the Division and develops background data pertinent for government programs; attends meetings, conferences, symposia and workshops of scientific organizations to stay current in his/her field of expertise and to exchange ideas with other scientists
- The Data Scientist undertakes other tasks as assigned, including, but not limited to, preparation of responses to requests for information from the Agency, congressional inquiries, or consumer groups; preparation and presentation to Advisory Committees or other scientific groups
- 1,001-5,000 employees
- Information Technology, Professional Services, Technology, Data Analytics, Computer Software, Information Technology and Services, Healthcare, Management Consulting, Computer & Network Security, Government
- Privately Held
- Reston, VA
- Company Specialties:
Big Data, Data Management, Business Intelligence, Mobile and Web Apps, Business Process Re-engineering, Business Process Management, artificial intelligence, intelligent automation, Information Management, and Digital Transformation
Company information
Brillient is an award-winning Full Spectrum Digital Transformation company enabling clients to transform through the continuum of analog, to digital, to analytics leading to insight-driven decision making and mission execution. We help clients achieve better efficiencies and lower costs in their digital government and IT modernization initiatives enabling friction-free interaction with citizens and business. We’ve worked with more than 22 federal agency clients over the past decade to increase efficiencies, combat waste, reduce costs, and improve citizen/customer satisfaction. In 2017 and 2019, Brillient was awarded Small Business of the Year by the Department of Homeland Security (DHS). Brillient has experienced stupendous growth making the Inc. 5000 list of fastest-growing private businesses in America, six times. Brillient's commitment to exemplary quality is evidenced by our CMMI Level 3, ISO 9001/20000/27001 certifications. Read more about our company at www.brillient.net
