Duties

Major duties to include but not limited to:

• Provides Biostatistical support during planning/conduct/analysis and publication of results phases of assigned multi-center clinical trials/studies.
• Provides statistical input and advice to clinical teams for the design of studies and sample size/power estimations. including the design, writing and review of study protocols, development of statistical analysis plans and development of analyses requiring advanced statistical methodologies.
• Design and lead the preparation of statistical components of protocols which meet study objectives, health authority guidelines, and clinical trial methodology standards.
• Provides clear and regular technical and administrative input to professional, technical, and administrative personnel assigned to a clinical trial.
• Ensure efficient and effective services in clinical trial administration, data management and statistical support.
• Ensures the assigned CSP studies are conducted according to most updated rules and regulations and ethics requirements (e.g., VA CSP guideline, HIPAA, FDA, ICH, GCP etc.).
• Initiates and conducts research activities involving modify existing statistical methods or developing new and innovative statistical methods for a specific study or of general interest.
• Provides expert consultation in support of other related and non-related CSP activities, upon request, e.g., preparation of literature searches as background for further research, and preparation of parts of internal documentation or proofreading documentation with researchers.
• Reviews the statistical programs, written by the assigned statistical programmer, which will be used to generate tables (as outlined in the SAP) and to create analytic datasets for interim analyses (as outlined in the protocol).
• Performs quality risk assessment of the proposed studies based on the Quality-by Design framework.
• Establish planning committees (following CSP Guidelines) for the assigned studies and to conduct pre-planning and planning meetings in collaboration with the principal proponent (or principal investigator (PI) of the study.
• Investigate the feasibility of conducting the proposed study within the VA by identifying available patient cohorts at different VA medical centers from VA's electronic health records.
• Assists the PI and the planning committee to initiate the process of medical center (study site) selection for the assigned studies.
• Takes a leadership role to monitor performance of the participating medical centers using an established risk-based monitoring approach.
• Takes a leadership role in obtaining regulatory approvals (cIRB, R&D etc.) for the assigned studies
• Prepares and submits the primary/secondary manuscripts in collaboration with the study PI(s) to peer-reviewed national and international journals.

Work Schedule: Monday - Friday, 8:00am-4:30pm
Remote: Available
Compressed/Flexible Schedule: Available
Virtual: This is not a virtual position.
Position Description/PD#: Statistician (Medicine)/PD22007O
Relocation/Recruitment Incentives: Not Authorized
Permanent Change of Station (PCS): Not Authorized
Financial Disclosure Report: Not required

Physical Requirements: The work is mostly sedentary.

This position is covered by AFGE bargaining unit. Per the AFGE Master Agreement, the Area of Consideration will be:
1st Area of Consideration: Current permanent Facility (including satellites) employees
2nd Area of Consideration: Current permanent VA employees (When announced outside of the agency, VEOAs must be considered on Internal Cert)
3rd Area of Consideration: All other Status candidates (if applicable)

Requirements

Conditions of Employment

• You must be a U.S. Citizen to apply for this job
• Selective Service Registration is required for males born after 12/31/1959
• You may be required to serve a probationary period
• Subject to background/security investigation
• Selected applicants will be required to complete an online onboarding process
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
• Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 12/09/2022

Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-13 position you must have served 52 weeks at the GS-12. The grade may have been in any occupation but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade.

To qualify for this position, all applicants must meet one of the following basic requirements:

Basic Requirements:

A. Degree:that included fifteen (15) semester hours in statistics (or in mathematics and statistics, provided at least six (6) semester hours were in statistics), and nine (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.

OR

B. Combination of education and experience: Courses as shown in A 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.

AND

In addition to meeting one of the basic requirements above, to qualify for this position at the GS-13 level, you must meet the following requirement:

GS-13 grade level: One year of specialized experience (equivalent to the GS-12 grade level in the federal service); experience that equipped the applicant with the particular knowledge, skills and abilities (KSA's) and other characteristics to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled, in the normal line of progression for the occupation in the organization. Specialized experience includes: Professional knowledge and experience in the following of the theories, principles, methods, and techniques of statistics in the research area of clinical trials and/or epidemiologic studies; statistical software packages such as, SAS, R, STATA etc. and software for sample size/power calculations, e.g., nQuery Advisor, NCSS PASS etc.; knowledge of and experience in health science and clinical investigation, biostatistics, and data processing; protocol development, data coordination, data processing, data analysis and report writing; applying statistical methods in clinical research, pharmaceutical, medical device, or Clinical Research Organization (CRO) experience is required; Interdisciplinary knowledge of medical terminology; reading medical journals; communicate effectively with investigators and provide necessary scientific and statistical support; ICH GCP guidelines, FDA regulations; pharma and/or medical device clinical trials and FDA submissions; adaptive design or pragmatic clinical trials, state-of-the-art modeling approaches; analyzing big data; oral and written communications skills for protocol development, professional exchange of information with clinicians and peers and generating formal reports and publication of study results; conducting cooperative clinical studies.

You will be rated on the following Competencies for this position:

Research: Knowledge of the scientific principles, methods, and processes used to conduct a systematic and objective inquiry; including study design, collection, analysis, and interpretation of data; and the reporting of results.
Analytical Reasoning: identifies issues and analyzes information to draw accurate conclusions, ensuring careful attention to detail. Dissects problems and information into their meaningful parts and uses logic and judgment to evaluate alternatives and develop solutions.
Communications: Effectively expresses information to multiple audiences through clear, convincing oral and written communications; demonstrates logical thinking when describing facts and concepts, and shapes communications to meet the needs of a specific audience; actively listens to others and demonstrates understanding of their comments and/or questions.
Leadership: Inspires, motivates and guides others toward goal accomplishment; coaches, mentors, and challenges subordinates; adapts leadership styles to a variety of situations; models high standards of honesty, integrity, trust, openness, and respect for the individual by applying these values to daily behaviors.
Customer Service: Works with clients and customers (that is, any individuals who use or receive the services or products that your work unit produces, including the general public, individuals who work in the agency, other agencies, or organizations outside the Government) to assess their needs, provide information or assistance, resolve their problems, or satisfy their expectations; knows about available products and services; is committed to providing quality products and services.
Standards Development Organization Operational Engagement: Understanding and experience in the policies, procedures and processes of Health Level 7 (HL7), the Object Management Group (OMG) or other ISO Standards Development Organization.

For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/ .

Education

A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

NOTE: Transcripts should state the name of the student, name of the university and/or college, total number of credits completed, date degree awarded/conferred. Copies of Official Transcripts are accepted and are the best way to ensure your education is interpreted correctly in accordance with OPM qualification standards, but unofficial transcripts are accepted if they contain all the required information. If credit for a course is being questioned by the HR Professional performing qualifications, it is your responsibility to provide supporting descriptive information (course syllabus/descriptions) in your application package.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/ . If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html .

Additional information

The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal/VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation (a copy of the agency notice, your most recent performance rating, and your most recent SF-50 noting current position, grade level, and duty location) and be found well-qualified for this vacancy. To be well-qualified : applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the required competencies of the job. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/ .

This job opportunity announcement may be used to fill additional vacancies.

Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process.

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .