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This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Silver Spring, MD. Positions may be filled in the following Centers: Center for Tobacco Products (CTP), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Affairs (ORA), Office of Operations (OO), Office of Commissioner (OC), and National Center for Toxicological Research (NCTR).
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
Additional selections may be made within the same geographical area FDA-wide.
12/29/2017 to 01/11/2018
$54,792 - $71,467 per year
GS 9
Many vacancies in the following locations:
Not required
Yes—May or may not be authorized
Permanent
Full-Time
12
No
FDA-CRT-18-DE-10090624-KBH
487638800
The incumbent may perform the following responsibilities: Collaborates with statistical reviewers and management on a variety of computationally intensive projects to support and improve the efficiency of regulatory product review and applied regulatory research. The incumbent works with multidisciplinary teams of scientists and a diverse array of stakeholders in a dynamic, highly challenging, and innovative atmosphere.
Working with division's management, team leaders and statistical reviewers, the incumbent plays a critical role in supporting the mission of advancing the product review process.
Works with the team leader and the statistical reviewer to provide statistical programming and data management support for review of the evidence related to an applicant's claims regarding safety, efficacy and benefit-risk in New Drug Applications (NDAs), Biologic License Applications (BLAs), and supplemental and abbreviated applications (sNDAs; ANDAs); assesses the quality and completeness of submissions with assistance from team leader and/or reviewer; prepares clinical trial analysis datasets; assists with communication with applicants regarding specifications for regulatory information requests; validates sponsor results; produces required tables, listings, and figures
As requested by senior staff, assists in analyzing epidemiological/observational data from health records, registries, natural history studies and contract databases to answer review questions concerning the life-cycle safety, efficacy and use of regulated drugs and biologics; assist in designing and producing code for methods development under the Sentinel initiative and other related programs, including Sentinel safety queries and assists in routine surveillance studies.
Assists in applying, documenting and archiving programs, processes, procedures and SOPs for management and handling of review and research data files and databases created and/or used by OB statistical reviewers for decision support and regulatory science research; assist in developing special-use databases; imports and exports data into specified formats using established fire-walled Agency servers; assists in implementing transformations needed to input clinical trial into data special use.
Additional Conditions of Employment:
You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm ET on 01/11/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
1. Knowledge of the application of statistical science, computational methodologies and research techniques.
2. Skill in the use of specialized statistical software.
3. Ability to communicate in writing.
4.Ability to communicate orally.
The following documents are ACCEPTED for this vacancy:
"Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.
The following documents are REQUIRED for this vacancy:
"Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.
DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO QUALIFY FOR SPECIAL APPOINTING AUTHORITIES:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
To apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section. To receive consideration for this position, you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement (01/11/2018)..
Instructions for applying to this job:
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (01/11/2018).
You will receive application status updates via email and via USAJOBS as the process unfolds.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/487638800. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
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