Data Scientist

1 day ago


Silver Spring MD United States Brillient Corporation Full time

Brillient is seeking an experienced Data Scientist to join our team supporting a federal contract in Silver Spring, MD. 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. 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 or military member. The employee should have significant expertise in data science.

Responsibilities
  • Reviews and evaluates 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.
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