Senior Statistician – Technical Operations (Pharma)

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

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.