AddressResponsibilities
- 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.
- 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.
- 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 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
