Senior Biostatistician - Avance Clinical Pty
  • Adelaide, Adelaide, Australia
  • via CareerWallet
-
Job Description

Join our Global CRO and growing biostats team

24th April, 2024

Avance Clinical - our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respects its people.

Responsibilities

  • Preparation and review of statistical analysis plans and randomization schedules.
  • Preparation and review of listings, tables and figures for interim analyses and clinical study reports.
  • Perform statistical analyses.
  • Review CDISC SDTM and ADaM specification documents.
  • Assist with preparation and review of clinical study reports.
  • Liaise with Clinical Project Managers, the Data Management team, and external vendors (e.g. bioanalytical laboratories).
  • Communicate with clients including discussion of processes, timelines and study results.
  • Review of Case Report Forms for data capture.
  • Monitor and report on study budgets and identify changes from contracted scope of work.
24th April, 2024

Avance Clinical - our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respects its people.

Responsibilities

  • Preparation and review of statistical analysis plans and randomization schedules.
  • Preparation and review of listings, tables and figures for interim analyses and clinical study reports.
  • Perform statistical analyses.
  • Review CDISC SDTM and ADaM specification documents.
  • Assist with preparation and review of clinical study reports.
  • Liaise with Clinical Project Managers, the Data Management team, and external vendors (e.g. bioanalytical laboratories).
  • Communicate with clients including discussion of processes, timelines and study results.
  • Review of Case Report Forms for data capture.
  • Monitor and report on study budgets and identify changes from contracted scope of work.
What you'll need to succeed
  • Ordinary degree in the appropriate discipline or appropriate industry experience.
  • Higher degree in relevant discipline to Biostatistics / Scientific research data analysis
  • Minimum 7 years' experience in statistical analysis in pharmaceutical / 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 at a high level with clients, senior management and other stakeholders.
  • Ability to work under pressure in a multi-disciplinary team environment.
Benefits
  • Reputable growing CRO with stability
  • Challenging and stimulating environment where what you do matters
  • A diverse and inclusive culture with a strong emphasis on team collaboration
  • Training and career development opportunities
  • Attractive remuneration
To apply
  • To apply for this role please click on the 'APPLY' link and submit your CV along with a cover letter outlining your skills and experience - please submit as one PDF document.
  • You must also have full Australian working rights to be considered.
  • Full time role
  • No agencies please
For Job

;