Statistician Tech Ops

CSL; Broadmeadows; On-site; AUD 120,000 - 160,000; Full time

Job summary

CSL Behring in Broadmeadows seeks an experienced Statistician to provide advanced statistical expertise across Operations, Quality, and Regulatory Affairs, supporting manufacturing and quality activities throughout the product lifecycle.

You will apply modern methods, collaborate with cross-functional teams, contribute to process improvement, and assist with regulatory submissions, while upholding data integrity and scientific rigor.

Qualifications

• Master’s or PhD in Statistics or Biostatistics required.
• 3–5 years of statistical analysis and data science in regulated industries.
• Experience supporting GMP and CPV within pharmaceutical or biotech settings.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Apply advanced statistical methodologies to support process understanding, product quality assessment, product stability, and lifecycle management.
• Utilize regression, mixed-effects, PCA, hypothesis testing, Bayesian methods, and ML where appropriate.
• Provide expert statistical consultation to cross-functional teams investigating manufacturing and quality challenges.
• Support regulatory submissions, inspections, and audits with sound statistical principles.
• Deliver training and knowledge-sharing to promote statistical capability.
• Lead investigations, deviations, CAPAs, root cause analyses through quantitative analysis.
• Identify trends and risks using advanced analytics to enable data-driven improvements.
• Lead comparability assessments for scale-up and technology transfers.

Skills

Statistics

Data Science

Machine Learning

Experimental Design

Regulatory/GxP knowledge

R

Python

Minitab

JMP

SQL

Education

Master’s or PhD in Statistics or Biostatistics

Tools

R / R Studio

Python

JMP

Minitab

SQL

Job description

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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit https://www.csl.com/Supports-Your-Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.