Your Role

CSL Seqirus is looking for a Biostatistician to join our MS&T (Manufacturing, Science & Technology) department at Parkville site.

This is a 1-year fixed term contract role.

Reporting to the MS&T Manager Process Sciences, you will provide statistics leadership and support for assigned projects to ensure provision of statistically sound and robust methodology in a wide range of activities. You will also provide support, strategy and guidance for all statistical analysis within the Quality and Manufacturing departments across the Seqirus Parkville, Liverpool and Holly Springs sites (as necessary).

Your Responsibilities

Reporting to the MS&T Manager Process Sciences Manager you will:

• Provide technical statistical expertise, leadership, and guidance to facilitate ongoing development and growth of Biostatistics to support projects aligned with strategic objectives,
• Assumes responsibility for methodological and statistical aspects of projects by ensuring strong statistical foundation underpins project strategy and provides sound strategic, statistical, and scientific input on program objectives, experimental design, and data analysis to meet regulatory and scientific requirements.
• Maintain comprehensive knowledge and awareness of developments and trends in theoretical and applied Statistical theory and Regulatory developments, in relation to the statistical methodology applicable in a non-clinical setting.
• Development and application of new and novel statistical techniques that are effective, efficient, and supporting innovation and efficiencies to projects.
• Provides training and guidance on the application of basic statistical methodology by staff across Quality, Manufacturing and QC.
• Liaise with internal Clinical Teams, external global Statisticians, vendors and Contract Testing Laboratories to maximise efficiencies in Clinical programs in relation to Serology activities.

• Masters in Biostatistics, plus undergraduate degree in a scientific field.
• Minimum five years related experience in applying statistical methodology in a Pharmaceutical/Biotechnology or industrial setting.
• Experience with a range of statistical software packages (JMP, STATA etc).
• Expertise and practical experience in use of advanced statistical methodologies, especially with application in a non-clinical setting.
• Strong understanding and knowledge of the statistical aspects of regulatory requirements and guidelines relating of pharmaceutical activities (TGA, FDA, EU/BP, ICH).
• Flexibility to meet deadlines while balancing many projects and customers simultaneously.
• Possess exceptional written and oral communication skills in explaining complex statistics in the context of experimental objectives to those with little or no background.
• Demonstrated high level of productivity, strong attention to detail and efficiency.
• Ability to provide statistical guidance and strategic advice to project teams.
• Demonstrate competent report writing skills.