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This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, 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), and Office of Regulatory Affairs (ORA), Office of Operations (OO), Office of Commissioner (OC), and National Center for Toxicological Research (NCTR).
12/29/2017 to 01/11/2018
$94,796 - $123,234 per year
GS 13
Many vacancies in the following locations:
Not required
No
Permanent
Full-Time
13
No
FDA-CRT-18-DE-10088339-KBH
487644100
The incumbent may perform the following responsibilities: For positions within CDER/CDRH/CBER: Serve as an expert in statistical methodology and review statistical methods for the analysis of data, primarily from clinical studies. Provide statistical regulatory support, evaluating and suggesting changes to clinical trial protocols, statistical methods, clinical trial design/conduct issues, and analyze data from clinical studies using specialized statistical software and general programming languages. Act as statistical consultant for a range of other problems, e.g. manufacturing quality, laboratory experimental design/analysis, survey statistics, psychometrics, epidemiology, decision analysis, quantitative risk analysis, Collaborate with other scientists in the evaluation of regulated studies and the conduct of primary research activities. Suggest changes to clinical trial protocols, including statistical methods, trial design and conduct issues. Perform statistical reviews of investigational applications such as Investigational New Drugs (INDs), Investigational New Animal Drugs (INADs) and Investigational Device Exemptions (IDEs), by evaluating proposals for the design, conduct, and analysis of regulated clinical studies. Perform statistical reviews of marketing applications such as Biologics License Applications (BLAs), New Drug Applications (NDAs), New Animal Drug Applications (NADAs), Premarket Approvals (PMAs) and Premarket Notifications [510(k)s] submissions and supplements for adequacy of design, conduct, analysis, and appropriateness of resulting inferences and conclusions. Verify applicants' critical statistical analyses and perform additional analyses as needed. Suggest and verify methods and analyses in pilot studies, clinical trials, laboratory studies and other research projects to ensure validity of inferences obtained from these studies. Represent the FDA in meetings and keep abreast of progress and potential problems. Work in collaborative multidisciplinary groups with scientists, engineers and physicians, translating medical questions and concerns into appropriate statistical analyses and communicating results. Collaborate with statisticians from sponsor companies and academic statisticians to develop new statistical methods and learn about new methods as they are being developed. Write summaries and develop reports and papers regarding statistical or clinical trial issues; give briefings/presentations to other statisticians, colleagues, FDA advisory panels, and upper management. Attend conferences to retain and enhance professional competency, and participates in activities of relevant professional societies.
For Positions within CFSAN: Provide statistical regulatory support, evaluate and analyze data from designed experiments, surveys, and observational studies using computational methods. Independently lead individual team effort to plan a statistical survey or study; develop novel statistically defensible solutions to technical issues; analyze large databases using signal detection, data and text mining methodology. Coordinate with CFSAN's Office of Compliance and FDA's Office of Regulatory (ORA) statisticians to develop sampling and inspection workplans for FDA field laboratories and investigators. Verify and validate methods and computations in pilot studies surveys, experiments, laboratory studies and final projects to assure the accuracy validity of results obtained from data obtained from these efforts. Design and analyze complex surveys and/or large multi-laboratory experiments; design experiments after consulting with project teams; select appropriate statistical methods for modeling and estimate generation, performing testing to identify outliers and assess departures from distributional assumptions, etc.
For Positions within CTP: Evaluate and integrate data from complex probability-based surveys, observational studies, designed experiments, and analysis of data from large dataset/databases; use mathematical and statistical programming and data processing using programs such as R/S-plus, C++, Matlab, Stata, Java, Perl and SAS; design biological and chemical experimental studies; provides support for microbial and chemical assay and method development. Conduct analysis of complex population level surveys, population projection modeling and micro-simulation models; ecometrics; econometrice dynamical systems, and systems biology simulation.
For Positions within CVM: Provide expertise, leadership, and coordination across the Center evaluating study protocols and review results from studies investigating the effectiveness and safety of animal drugs, food/feed, food additives, and other related applications. Provide statistical consultation for effectiveness and safety studies, research projects, and other work. Use statistical and mathematical methods to draw inferences from data and to facilitate the Center's scientists in study design, data analysis, and data interpretation.
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.
Evaluation of Education:
Courses acceptable toward meeting the mathematics course requirement of paragraphs A or B above must include at least four of the following: differential calculus, integral calculus, advanced calculus, theory or equations, vector analysis, advanced algebra, linear algebra, mathematical logic, differential equations, or any other advanced course in mathematics for which one of these was a prerequisite. Courses in mathematical statistics or probability theory with a prerequisite of elementary calculus or more advanced courses will be accepted toward meeting the mathematics requirements, with the provision that the same course cannot be counted toward both the mathematics and the statistics requirements.
Unofficial transcripts are issued by the registrar's office at your college or university and have the following information listed:
-Name of the college or university, a watermark and/or the school seal
-The month and or year when you officially began and ended your coursework
-The name of program/major/curriculum of study
-The timeframe in which the semester/quarter courses were taken
-The total credit hours and grades earned for each course
?Additionally, please submit all transcripts that may help you met the basic education requirement. If you have more than one degree, please save/scan each transcript separately.
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 principles, theories and applications of statistical methodologies.
2. Ability to analyze and interpret statistical results and develop techniques and methodologies.
3. Skill in mathematical and statistical theory and design problem solving.
4. Ability to analyze statistical data and make recommendations.
5. Ability to communicate in writing.
6. 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/487644100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
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