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Statistical Programmer II

Statistical Programmer II

O
OraClinical research
Remote - USFull-TimeMiddle
Salary not disclosed
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Job Details

Experience
Two (2) to four (4) years of relevant professional experience

Requirements

  • Bachelor's degree in computer science, statistics, or another related scientific field, or an equivalent combination of relevant education and experience.
  • Two to four years of relevant professional experience, or an equivalent combination of relevant education and experience.
  • Proficient SAS programming skills.
  • Expert knowledge of SAS/Base.
  • Working knowledge of SAS/Stat and SAS Macros.
  • Basic understanding of SAS/Graph.
  • Experience manipulating and analyzing SAS data.
  • Analytical skills to process scientific and medical data.
  • Ability to identify data issues, explain problems clearly, and implement effective solutions.
  • Familiarity with clinical trial design and analysis activities.
  • Basic knowledge of regulatory guidelines, including FDA/CFR and ICH/GCP.
  • BASE SAS and Advanced SAS Certification or equivalent experience preferred.

Responsibilities

  • Perform assigned statistical programming for clinical trial analysis and reporting.
  • Review Statistical Analysis Plans in preparation for programming analyses.
  • Apply appropriate statistical methods to data analysis.
  • Assist in designing and developing SAS macros and utilities.
  • Generate tables, listings, and figures according to protocols, Statistical Analysis Plans, or approved client requests.
  • Participate in statistical program validation and quality control activities.
  • Program and validate CDISC SDTM and ADaM datasets, and assist with SDTM aCRF and specifications.
  • Develop define.xml and create program tables of contents for regulatory submissions.
  • Program data-cleaning checks and use the project infrastructure for SAS datasets and code.
  • Coordinate with Clinical Operations, Project Management, and Data Management on project execution.
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