Advanced Statistical Analyst

3 days ago

Adelaide, South Australia beBeeStatistical Full time $90,000 - $105,000

We are seeking a highly skilled Statistical Programmer to join our team based in Adelaide. As a key member of our data management group, you will play a crucial role in ensuring the quality and integrity of clinical study reports.

Responsibilities
  • Data Analysis: Prepare listings, tables and figures for clinical study reports using advanced statistical programming techniques.
  • Programming: Create primary and QC SAS programs for CDISC datasets and associated documentation, adhering to regulatory guidelines.
  • Project Coordination: Assist with the preparation of statistical analysis plans, including the review and preparation of listing, table and figure shells, and randomization schedules.
  • Collaboration: Liaise with Data Management team and bioanalytical laboratories regarding data transfer and ensure seamless collaboration throughout the project lifecycle.
  • Process Improvement: Maintain and coordinate CDISC standards, promote maximum reuse of applied standards, and contribute to ongoing process improvement initiatives.
  • Professional Development: Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation.
Requirements
  • Education: Ordinary degree in a relevant discipline or equivalent industry experience.
  • Experience: Minimum 2 years' experience in statistical programming in pharmaceutical/health research.
  • Skill Set: Strong CDISC knowledge and SDTM conversion experience; development, documentation, and testing of analysis data and programming code to meet regulatory and company standards; formal training in SAS programming (desirable).
  • Clinical Knowledge: Familiarity with ICH GCP Guidelines, medical terminology, and clinical trials processes.
  • Technical Skills: Excellent MS Word and Excel skills, ability to work with various software applications.
  • Presentation Skills: Excellent verbal and written communication skills, ability to present complex ideas effectively.
  • Team Player: Demonstrated initiative, trust, reliability, and ability to work unsupervised in a dynamic team environment.

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