SAS Programmer

Tunnell Government Services, Inc.

$95K — $115K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in SAS programming within a clinical research environment
  • Strong understanding of CDISC standards including SDTM and ADaM
  • Proficient in developing statistical analysis plans and validation reports
  • Experience producing tables, listings, and figures for clinical studies
  • Ability to respond proficiently to regulatory requests from sponsors and the FDA
  • Skilled in the development of randomization lists and keys

Responsibilities

  • Prepare and maintain statistical analysis plans and programming validation plans
  • Develop randomization plans and associated statistical programs
  • Create statistical programming specifications for generating clinical data reports
  • Produce data-populated tables, listings, and figures for study purposes
  • Develop CDISC-compliant datasets and documentation including define.xml
  • Ensure adherence to CDISC guidelines during dataset development
  • Provide written responses to regulatory inquiries related to statistical products

Benefits

  • Health, dental, and vision insurance options
  • 401(k) retirement savings plan
  • Generous paid time off and holidays
  • Opportunities for professional development and training
  • Flexible work arrangements may be available
Full Job Description
Title: SAS Programmer Deliverables: - 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 Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

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