The Role
Develop and maintain statistical analysis and programming validation plans, randomization programs, clinical study tables, listings, and figures. Create CDISC-compliant SDTM, ADaM, and SEND datasets, define.xml and define.pdf documentation, reviewer’s guides, and responses to sponsor and FDA queries. The role supports regulated military health research activities at Fort Detrick and requires U.S. citizenship, background investigation, and eligibility for a government security clearance.
Summary Generated by Built In
SAS Programmer
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 SAS Programmer 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:
- 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
- Compliance 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.
