The Role
Provides senior biostatistical and clinical data management support for military health research programs. Responsibilities include developing data management, statistical analysis, randomization, and validation plans; creating statistical programming specifications; producing tables, listings, and figures; developing CDISC-compliant SDTM, ADaM, and SEND datasets; preparing reviewer guides and define files; and responding to sponsor and FDA queries.
Summary Generated by Built In
Senior Biostatistician
About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact.
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Location(s): Fort Detrick, MD
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Position Details:
- Full-time position
- Regular weekly hours (0900-1600)
- No calls, nights, weekends, or holidays!
- Full benefit program, including: health, PTO, & 401k + contribution
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Requirements:
- TBD
Summary:
CICONIX is seeking a Senior Biostatistician to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD.
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About the Role:
- Provide clinical data management support according to the applicable FDA regulations, guidance, and industry standards. Data management support includes performing clinical data management activities or providing clinical data management oversight, support responsibilities. Provide biostatistical support and deliverables that meet the applicable regulations, guidance, and standards, including industry standards (clinical and nonclinical). Biostatistical support includes performing biostatistical support or providing statistical oversight activities, but is not limited to the following:
- Develop a Data Management Plan (Deliverable 17), which is a comprehensive document developed to describe all data management activities and their processes and implementation during pre-study conduct, study conduct, and study closure and that reflect Good Data Management Practices based on Good Clinical Data Management Practices (GCDMP), Good Clinical Practices, and ICH guidelines.
- Develop Case Report Forms (CRFs), which are a series of questionnaire forms used as a data collection instrument for accurately and completely capturing the data required by the clinical protocol, that meet the FDA submission requirements and conform to Clinical Data Interchange Standards Consortium (CDISC)/ Clinical Data Acquisition Standard Harmonization (CDASH) standards and Study Data Tabulation Model (SDTM) controlled terminology.
- Prepare, update, and maintain all versions of statistical analysis plans.
- Prepare, update, and maintain all versions of Statistical Programming Validation Plans, and all versions of statistical programming validation reports; Develop and provide statistical program formats used in the statistical programs (all versions).
- Prepare, update, and maintain all versions of randomization plans including randomization list(s) and key(s), prepare statistical programs used to create randomization list(s) and key(s).
- Develop statistical programming specifications (clinical data) and other statistical programs used to produce the tables, listings, and figures for studies, all versions used for the Data Monitoring Committee, safety surveillance plans, FDA annual report, interim analyses (if applicable), and any ad hoc analyses.
- Produce data-populated tables, listing, and figures for studies, the Data Monitoring Committee, safety surveillance plans, FDA annual reports, interim analyses (if applicable), and any ad hoc analyses.
- Develop and revise as required statistical programming specifications used to create CDISC-compliant datasets, SDTM, Analysis Data Model datasets, and Standard for Exchange of Nonclinical Data (SEND) (for non-clinical data); Develop define.xml and define.pdf to include coding conventions used in the statistical programs (all versions) for CDISC datasets; Develop SEND datasets conforming to CDISC standards (non-clinical data); Develop SDTM datasets conforming to CDISC standards; Develop Analysis Data Model datasets conforming to CDISC standards as required.
- Develop and update as required by CDISC Reviewer’s Guides.
- Provide written responses to sponsor and FDA requests/queries regarding statistical products.
Qualifications:
- Education:
- TBD
- Licensure & Certifications (Current & Unrestricted):
- TBD
- Experience:
- TBD
- Security & Background Check:
- U.S. Citizenship and a successful background investigation are required.
- Ability to obtain and maintain a government security clearance.
- Additional Requirements:
- Willingness to comply with the government vaccination requirements.
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Compensation: TBD
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*This position is contingent and will begin upon contract award.
CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
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Skills Required
- U.S. citizenship
- Successful background investigation
- Ability to obtain and maintain a government security clearance
- Willingness to comply with government vaccination requirements
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The Company
What We Do
CICONIX is a veteran-owned small business that provides business advisory and technical assistance, with an emphasis on military and Veterans healthcare programs. Its services span medical research and development, operational medicine support, health information management and technology, organizational development and training, clinical support, program development and management advisory services, Lean training, and healthcare talent acquisition for government and healthcare clients.
