Senior Statistical Programmer

Company: Katalyst HealthCares & Life Sciences
Location: West Jordan
Posted on: March 17, 2023

Job Description:

Job Description

Responsibilities:

• Input into and negotiate statistical programming timelines.
• Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
• Monitor project resourcing, project budgets, and identify changes in scope
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
• Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities Requirements:
  • Proficiency in SAS
  • Knowledge of the programming and reporting process
  • Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-Google Cloud Platform and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Strong leadership skills
  • Ability to successfully work together with a ("virtual") team (including international teams as required) as well as independently
  • Excellent analytical skills
  • Effective time management in order to meet daily metrics or team objectives
  • 5+ years proficiency in SAS programming
  • 2+ years of ADaM, CDISC or SDTM
  • Lead experience in a Pharma setting
  • Attention to detail, ability to be self-driven and solid organization skills
  • Excellent communication skills (verbal and written)

Keywords: Katalyst HealthCares & Life Sciences, West Jordan , Senior Statistical Programmer, IT / Software / Systems , West Jordan, Utah