Data Analysis Specialist

11 hours ago

Sydney, New South Wales, Australia Avance Clinical Pty Full time

At Avance Clinical Pty, we value our people and offer a fun, friendly work environment. Our culture respects honesty and promotes teamwork.

Job Description

We are seeking a skilled Data Analysis Specialist to join our growing biostats team. As a Senior Biostatistician, you will be responsible for:

  • Preparing and reviewing statistical analysis plans and randomization schedules.
  • Preparing and reviewing listings, tables, and figures for interim analyses and clinical study reports.
  • Performing statistical analyses.
  • Reviewing CDISC SDTM and ADaM specification documents.
  • Assisting with preparation and review of clinical study reports.
  • Liaising with Clinical Project Managers, the Data Management team, and external vendors.
  • Communicating with clients regarding processes, timelines, and study results.
  • Reviewing Case Report Forms for data capture.
  • Monitoring and reporting on study budgets and identifying changes from contracted scope of work.
Requirements

To succeed in this role, you will need:

  • An ordinary degree in the appropriate discipline or relevant industry experience.
  • A higher degree in a relevant discipline, such as Biostatistics or Scientific Research Data Analysis.
  • A minimum of 5 years' experience in statistical analysis in pharmaceutical or health research.
  • Working knowledge of ICH GCP Guidelines, medical terminology, and clinical trials processes.
  • SAS programming experience (highly desirable).
  • Working knowledge of CDISC SDTM and ADaM implementation and requirements (highly desirable).
  • Understanding of pharmacokinetics (desirable).
  • Ability to communicate effectively with clients, senior management, and other stakeholders.
  • Ability to work under pressure in a multi-disciplinary team environment.
Benefits

We offer a reputable, growing CRO with stability, a challenging and stimulating environment, a diverse and inclusive culture, training and career development opportunities, attractive remuneration, and remote work arrangements.

This is a full-time role that requires Australian working rights. Please submit your CV and a cover letter outlining your skills and experience as one PDF document. No agencies please.

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