Senior Biostatistician

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

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