Clinical/Medical Research (Healthcare & Medical)
Full time
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 5 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. Remote work/ office based/ hybrid arrangements available. 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. #J-18808-Ljbffr