The Opportunity
At CSL, we're driven by our promise to save lives and protect the health of people around the world. We are seeking an experienced Statistician to join our Technical Operations team to provide advanced statistical expertise across the site including Operations, Quality, Regulatory Affairs to support critical manufacturing and quality activities throughout the product lifecycle, process performance, investigations and continuous improvement initiatives.
Your Responsibilities
Based at Broadmeadows and working within a global team you will:
- Apply advanced statistical methodologies to support process understanding, product quality assessment, product stability, and product lifecycle management activities.
- Utilize a range of statistical techniques including regression analysis, mixed-effects models, multivariate analysis, principal component analysis (PCA), hypothesis testing, simulation methods, Bayesian approaches, and machine learning where appropriate.
- Provide expert statistical consultation and scientific support to cross-functional teams investigating complex manufacturing and quality challenges.
- Support regulatory submissions, inspections, and audits through the application of sound statistical principles and best practices.
- Deliver training and knowledge-sharing initiatives to promote statistical capability across the business.
- Support investigations, deviations, CAPAs, and root cause analyses through quantitative analysis and evidence-based recommendations.
- Identify trends, risks, and opportunities using advanced analytics to support digital solutions and data-driven process improvements.
- Lead statistical comparability assessments supporting process optimisation, scale-up activities, technology transfers, site transfers, and major product or process changes.
Your qualifications and experience
To be successful in this role you will bring:
- Master's Degree or PhD in Statistics, Biostatistics, Data Science, Applied Mathematics, Engineering, or a related quantitative discipline.
- 3-5 years' experience in statistical analysis and data science within the pharmaceutical, biotechnology, medical device, or other regulated industry.
- Experience supporting manufacturing, process development, quality, or technical operations functions in a GxP-regulated environment.
- Knowledge of statistical process control (SPC), process validation, Continued Process Verification (CPV), product lifecycle management, and comparability assessments.
- Experience working within and understanding of GMP requirements is highly desirable.
- Strong expertise in statistical methods, experimental design, process monitoring, and multivariate analysis.
- Proficiency in statistical software and programming tools including R / R Studio, Python, JMP and Minitab.
- Experience working with SQL and data extraction tools.
- Experience working effectively within multidisciplinary and cross-functional teams.
- Exposure to machine learning and advanced analytics applications within manufacturing environments is desirable.
- Excellent communication, stakeholder engagement, and presentation skills.
- Strong analytical and problem-solving capabilities.
- Ability to translate complex statistical concepts into practical, business-focused recommendations.
- Strong scientific mindset with a commitment to data integrity and attention to detail.
- Ability to manage multiple priorities in a dynamic and evolving environment.
If this sounds like you and you want to contribute to patient health globally, apply now!
