Job Description

• Full-time position
• Regular weekly hours (0900-1600)
• No calls, nights, weekends, or holidays!
• Full benefit program, including: health, PTO, & 401k + contribution

• TBD

• 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.

• 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.