Mathematical Statistician, GS-1529-12

Employer
USAJobs
Location
Washington D.C.
Posted
Jul 28, 2017
Closes
Aug 16, 2017
Function
Administrative
Hours
Full Time
JOB SUMMARY:

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.

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 Biologics & Evaluation Research (CBER) - Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. To ensure the safety, purity, potency, and effectiveness of biological products.

Center for Drug Evaluation & Research (CDER) Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.

Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.

Center for Tobacco Products (CTP) - Responsible for implementing the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products and manufacturers based on the best available science and for both assessing and fostering that science base.

Office of Regulatory Affairs (ORA) –Inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.

National Center for Toxicological Research (NCTR) - Provides the field offices with coordinated direction, assistance, and management for investigational activities in international arenas.

Center for Veterinary Medicine (CVM) - Conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals; and monitors the safety and effectiveness of animal drugs on the market.


Who May Apply: Open to all United States Citizens.

Additional selections may be made within the same geographical area FDA-wide.


TRAVEL REQUIRED:
  • Not Required

RELOCATION AUTHORIZED:
  • No

KEY REQUIREMENTS:
  • U.S. Citizenship is required.
  • Only experience gained by closing date announcement will be considered.
  • One year probationary period may be required.
  • Official transcripts required.
  • Basic Requirement: Applicants must meet one of the following:
    Degree; that included 24 semester hours of mathematics and statistics, of which at least 12 semester hours were in mathematics and 6 semester hours were in statistics.  (Must provide transcript(s) at time of application submission).
    OR
    Combination of education and experience -- at least 24 semester hours of mathematics and statistics, including at least 12 hours in mathematics and 6 hours in statistics, as shown in A above, plus appropriate experience or additional education (Must provide transcript(s) at time of application submission).

    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.

    All applicants must submit unofficial transcripts to receive consideration and confirm that you meet the basic education requirements of the position.  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

    Self-generated course lists or print outs from your student account are not acceptable.  Additionally, please submit all transcripts that may help you met the basic education requirement.  For example, if you have a Ph.D or Master's degree please provide copies of those transcripts as well as transcripts from previous degrees that may illustrate you met some or all of the basic education requirements.  If you have more than one degree, please save/scan each transcript separately.


    Specialized Experience Requirement:
    In addition to the basic requirement, you must have one (1) year of specialized experience to at least the GS-11 level in the Federal Government, to include experience in clinical trial protocols, clinical studies, observational studies; demonstrated work experience in one or more of the following: survival analysis, general and generalized linear models, longitudinal data analysis, missing data methods, Bayesian methods, ROC analysis, diagnostic statistics, bioassay methodology, computational statistics, propensity scores, adaptive designs, genetic statistics, or development of statistical methodology; experience programming and data processing using statistical software; experience contributing to publications and/or articles; presenting findings to internal stakeholders.

    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.

    Conditions of Employment: 
    1. Security and Background Requirements:  If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time.  Applicants are also advised that all information concerning qualifications is subject to investigation.  False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action. 
    2. E-Verify:  If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.  Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.  The U.S. Department of Health and Human Services is an E-Verify Participant. 
    3. Direct Deposit:  All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.  
    4. Pre-employment physical required: No
    5. Drug testing required: No
    6. License required:  No
    7. Mobility agreement required:  No
    8. Moving expenses authorized:  may be authorized. 
    9. Immunization required:  No
    10.Relocation Incentive may be authorized.
    11. Recruitment Incentive may be authorized.
    12. Retention incentive may be authorized upon the completion of one year of FDA federal experience, satisfactory completion of a probationary/trial period, and upon receipt of an “Achieved Expected” or higher performance rating.
    13. Student loan repayment incentive may be authorized.
    14. Annual leave for non-federal service may be authorized.
    15. Bargaining Unit Position: Yes
    16. Please be advised that this position will be subject to FDA’s strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests.  Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.

    Not Applicable


    DUTIES:

    For Positions within CDER/CDRH/CBER: Serve as a specialist in statistical methodology and reviews 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, analyzes 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, etc. Collaborate with other FDA 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), 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 Notification [510(k)s] submission and supplements for adequacy of design, conduct, analysis, and appropriateness of resulting inferences and conclusions. Verify applicants' critical statistical analyses and performs additional analyses as needed. Suggest and verify methods, 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 supervisor 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, develops reports and papers regarding statistical or clinical trial issues; give briefings/presentations to other statisticians, other professional colleagues, FDA advisory panels, and upper management. Maintain knowledge of the professional literature of the field. 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. Coordinate with CFSAN's Office of Compliance (OC) and FDA's Office of Regulatory Affairs (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 ensure the accuracy of data validity and conclusions of data obtained from 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; perform 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; econometrics; econometrice dynamical systems, 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. They provide statistical consultation for effectiveness and safety studies, research projects, and other work. They 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.