Demo

Statistical Programmer

Katalyst CRO
Charlotte, NC Contractor
POSTED ON 4/26/2025
AVAILABLE BEFORE 5/25/2025
Responsibilities

  • Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs.
  • Creates and reviews annotated CRF to SDTM datasets.
  • Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives.
  • Functions as a positive role model for setting high expectations for quality, creativity and project ownership.
  • Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers).
  • Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
  • Involved with the strategy for process improvement.
  • Identifies new tools to increase efficiency and quality.

Requirements:

  • Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
  • Minimum of 5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
  • Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus.
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies.
  • Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regards to statistical programming processes, management of statistical programming projects.
  • Excellent organizational skills and ability to prioritize tasks.

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