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.
Summary
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.
The incumbent may perform the following responsibilities: 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; prepares clinical trial analysis datasets; interprets the applicant's programs; assists with communication with applicants regarding specifications for regulatory information requests; validates sponsor results; produces required tables, listings, and figures.
Analyzes 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; assists 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.
S/he assist 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 statistical reviewers for decision support and regulatory science research; assists in developing special-use databases; imports and exports data into specified formats using established fire-walled Agency servers; utilizes tools to facilitate the transformations needed to input clinical trial data into special use databases; assists in integrating data from multiple studies for meta-analytical approaches needed for the study of issues associated with particular classes of drugs and biologics.
Assist in assessing requirements and planning the design and validation of statistical programming code to apply quantitative and graphical approaches within the regulatory review and research environment. Assist in developing statistical programming solutions across projects and/or technologies to meet internal regulatory review and research needs. Plans and coordinates statistical programming for complex studies; develops, validates, implements, documents, maintains, and supports programming tools and software in accordance with standards and accepted validation procedures. Supports efforts to develop document and apply reusable code and/or tools. Develops software using the appropriate statistical programming packages (e.g., R, JAGS, SAS ) for OB statistical reviewers to support programming intensive review-related activities, such as, sensitivity analysis, Bayesian approaches, clinical trials modeling, genomic studies, psychometric Clinical Outcome Assessment (COA) validation and simulation.
U.S. Citizenship is required for federal employment.
Only experience gained by the announcement closing date will be considered.
A 1-year probationary period may be required for some positions.
Selective Service registration is required for certain males based on DOB.
A background check to determine suitability for Federal employment.
Additional Conditions of Employment:
Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. 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 or appropriate disciplinary action.
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.
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Pre-employment physical required: No
Drug testing required: No
License required: No
Mobility agreement required: No
Immunization required: No
Bargaining Unit Position: Yes
Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid.
Financial disclosure statement, OGE-450, required:
Please be advised that this position will be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
All qualification requirements must be met by 11:59 pm (Eastern Time) on 01/11/2018.
Qualifications
Basic Qualification Requirement:
A. Degree: that included 15 semester hours in statistics or in mathematics and statistics, provided at least 6 semester hours were in statistics, and 9 additional semester hours in one or more of the following: physical or biological sciences, medicine, education, or engineering; or in the social sciences including demography, history, economics, social welfare, geography, international relations, social or cultural anthropology, health sociology, political science, public administration, psychology, etc. Credit toward meeting statistical course requirements should be given for courses in which 50 percent of the course content appears to be statistical methods, e.g., courses that included studies in research methods in psychology or economics such as tests and measurements or business cycles, or courses in methods of processing mass statistical data such as tabulating methods or electronic data processing. (Must provide transcript(s) at the time of application submission).
OR
B. Combination of education and experience -- courses as shown above, plus appropriate experience or additional education. The experience should have included a full range of professional statistical work such as (a) sampling, (b) collecting, computing, and analyzing statistical data, and (c) applying statistical techniques such as measurement of central tendency, dispersion, skewness, sampling error, simple and multiple correlation, analysis of variance, and tests of significance.
Minimum Qualification Requirements:
In addition to the basic requirement, you must have one (1) year of specialized experience equivalent to at least the GS-9 level in the Federal service, to include experience in clinical trial protocols, clinical studies, observational studies; professional statistical work such as (a) sampling, (b) collecting, computing, and analyzing statistical data, and (c) applying statistical techniques such as measurement of central tendency, dispersion, skewness, sampling error, simple and multiple correlation, analysis of variance, and tests of significance.
OR
Have a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related.
Education
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 requirements 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.
Additional information
If you are serving, or have served in the last 5 years (from 01/11/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM
Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Disability Employment
Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Workforce Restructuring
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How you will be evaluated
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 applications of statistical science, computational methodologies and research technique.
2. Ability to analyze and interpret statistical results and develop techniques and methodologies.
3. Skill in the use of specialized statistical software.
4. Skill in evaluation of data standards and data quality in a research environment.
5. Ability to communicate in writing.
6. Ability to communicate orally.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
The following documents are ACCEPTED for this vacancy:
Cover Letter
DD-214
ICTAP/CTAP Documentation
VA LTR
Resume
SF-15
SF-50
Transcript
"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:
Resume
Transcript
"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:
Veterans: veteran eligibility documentation (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM Guide to Career Transition for more information.
If you are relying on your education to meet qualification requirements:
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:
You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
If you are signed in, you can tap/click "Apply Online" to begin the process.
USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help site.
USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.
You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
Instructions for reviewing or editing your application:
If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".
You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.
You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
You are encouraged to apply online. Applying online will allow you to review and track the status of your application. This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10090909.) Decisions on granting reasonable accommodation will be made on a case-by-case basis.
FDA Office of Operations
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
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.
The following documents are ACCEPTED for this vacancy:
Cover Letter
DD-214
ICTAP/CTAP Documentation
VA LTR
Resume
SF-15
SF-50
Transcript
"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:
Resume
Transcript
"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:
Veterans: veteran eligibility documentation (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM Guide to Career Transition for more information.
If you are relying on your education to meet qualification requirements:
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:
You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
If you are signed in, you can tap/click "Apply Online" to begin the process.
USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help site.
USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.
You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
Instructions for reviewing or editing your application:
If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".
You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.
You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
You are encouraged to apply online. Applying online will allow you to review and track the status of your application. This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10090909.) Decisions on granting reasonable accommodation will be made on a case-by-case basis.
FDA Office of Operations
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
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.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
