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Company:
CSL Seqirus
Location:
AU -
melbourne parkville
Posted: June 21, 2024
The Opportunity
CSL Seqirus is looking for a Biostatistician to join our MS&T (Manufacturing, Science & Technology) department at Parkville site.
This is a 12-month fixed term contract role (maternity leave cover).
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).
The Role
- Provide technical statistical expertise, leadership and guidance to facilitate ongoing development and growth of Biostatistics to support projects aligned with strategic objectives.
- Assume 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.
- Provide 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.
Your skills and experience
- Degree in Biostatistics.
- 4+ years of experience in applying statistical methodology in a Pharmaceutical /Biotechnology industry.
- 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).
- Experience with a range of statistical software packages (JMP, STATA etc.) will be highly valued.
- Ability to provide statistical guidance and strategic advice to project teams.
How to apply
Please submit your application including your CV and cover letter by 12 July 2024.
#LI-Hybrid
Our BenefitsCSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
Learn more about some of the benefits you can participate in when you join CSL Seqirus.
CSL Seqirus is part of CSL Limited (ASX:
CSL).
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines.
Learn more about CSL Seqirus.
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL Seqirus.
Watch our 'On the Front Line' video to learn more about CSL Seqirus
Read the full job description and apply online on the recuiter's web-site
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