Our client is a full-service clinical contract research organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.
About the opportunity
Reporting into the Statistics Team Manager / Senior Biostatistician, the Biostatistician is accountable for analysing, interpreting, and preparing statistical data to ensure accurate reporting of results from clinical study data. The role assists with the investigational planning and strategy of clinical trials.
Preparation of listings, tables, and figures for clinical study reports.
Formulation of statistical plans and randomisation schedules.
Conduct statistical analyses.
Help with internal review of clinical study reports.
Coordinate with Data Management team about data transfer.
Assist with pharmacokinetic analyses.
Interact with bioanalytical laboratories about data transfer.
Assist with preparation and review of clinical study reports.
Review of Data Management Plan and Case Report Forms.
Preparation and review of Edit Check Document.
Skills and Experience
Degree in the appropriate discipline or appropriate industry experience
Higher degree in relevant discipline to Biostatistics / Pharmacokinetics (highly desirable)
Minimum 2-3 years' experience in statistical analysis in pharmaceutical / health research
Working knowledge of ICH GCP Guidelines, medical terminology, and clinical trials processes
SAS programming experience is desirable not essential
Understanding of pharmacokinetics is desirable not essential.
Excellent oral and written communications skills including the ability to prepare reports and procedures.
Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions, and coordinate a number of tasks simultaneously.
Proven ability to deliver tasks on time and with a high degree of accuracy.
Ability to work under pressure
Exhibited initiative, trust and reliability and the ability to work unsupervised.
Intermediate to advanced MS Word and Excel.
Why this opportunity is right for you
Fantastic opportunity to work with a fast-growing CRO
Internal growth opportunities
Inclusive and supportive Culture
Home office package
How to Apply
Click apply or contact Maddy Rhodes-Laird, Senior Recruitment Consultant on 03 9938 7101 for a confidential discussion.