Description

General Summary: This role will support the OCE data science workstream including data aggregation and analytic projects to support both regulatory review and regulatory science.

Essential Job Functions:

The individual mustbe processed through eArrive and have network access before assuming duties under this Call.

1. Reviews and evaluate clinical study protocols and reports submitted in NDAs, supplemental NDAs, new INDs, new protocols and protocol amendments, and Emergency INDs.
2. The contractor shall compile data to prepare special reports related to the work of OCE and develops background data pertinent for OCE programs.
3. The contractor will assist FDA scientists in the aggregation and visualization of FDAs internal clinical trial datasets to facilitate regulatory science and advance innovative trial designs, endpoints and other drug development tools.
4. The contractor will attend meetings, conferences, symposia and workshops of scientific organizations to stay current in the designated area of expertise and to exchange ideas with other scientists.
5. Other related duties as assigned.

Education Requirement: Master’s or Doctoral degree in Data Science, Statistics, Biostatistics, Mathematics, Computer Science, Physics, or a closely related quantitative discipline, with at least 3 years of work experience in data analytics/informatics.

Skills and Qualifications:

• Strong problem-solving skills and understanding of clinical relevance.
• Experience using computer languages (for example: Python, R, MATLAB, SAS, etc.) to manipulate data and draw insights from large datasets.
• Excellent written and verbal communication skills.
• Knowledge and experience with a variety of machine learning algorithms and statistical modeling (clustering, decision tree learning, ANN, KM method etc.).
• Self-motivated to learn and master new technologies and techniques.
• Able to work in a fast-paced team environment.
• Experience analyzing cancer clinical trial datasets.

Preferred, but not required: 

• Familiar with CDISC format.
• Experience with publishing research papers or present research in conferences

Experience Requirement: Minimum twelve (12) years of specialized experience in operations or management relevant to the applicable task; or clearly demonstrated to the selecting official, through prior job performance or education, an ability to perform the duties of this position.

Other Requirement(s): This position requires U.S. Citizenship or a Green Card holder and the ability to obtain and maintain a Government public trust level security clearance. For a candidate that is a Green Card holder, they 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.

Performance Requirements:

1. Excellent verbal and written communication skills.
2. Excellent interpersonal and customer service skills.
3. Familiar with a variety of the field’s concepts, practices and procedures.
4. Proficient in Microsoft Office Suite and Adobe Creative Suite.
5. Demonstrated skills in writing and editing.
6. Thorough knowledge of media operations.
7. Demonstrated success in implementing strong communication campaigns.
8. Excellent organizational skills, attention to detail and ability to manage workload and prioritize appropriately.
9. Excellent problem-solving skills with ability to analyze situations, identify existing or potential problems and recommend solutions.
10. Ability to work independently as well as collaboratively as a member of a team.
11. Experience analyzing cancer clinical trial datasets.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Work performed in an office environment. Involves frequent contact with staff and customers.

Mental/Physical Requirements: Manual dexterity for office machine operation; stooping, bending to handle files and supplies, mobility to complete errands or deliveries. Must be able to remain in stationary position for extended periods of time. Stress can be triggered by multiple demands and deadlines. 

DISCLAIMER: The above statements are intended to describe the general nature and level of work performed. They are not intended to be an exhaustive list of all responsibilities, duties, skills, efforts, requirements, or working conditions. Management reserves the right to revise the job or to require that other or different tasks be performed as assigned in accordance with business demands and/or contractual requirements.