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Associate Director, Biostatistics

CSL
Victoria
26 days ago

Description

The Opportunity:

 CSL has an exciting opportunity available for an Associate Director, Biostatistics to join our team in Melbourne. This position is responsible for providing statistical oversight of the global Product Development departments.

 The Associate Director, Biostatistics will  support high quality, efficiency, and the satisfaction of regulatory requirements within the Product Development (PD) Groups through the application of statistics, analytics, process control and the design of experiments; efficient and accurate information processing; and the implementation of data standards.    

 As a senior member of the team, you will develop national and international collaborations (internal and external) with the goal of improving the delivery of innovative advanced analytics methods to stakeholders at different levels within the organization.



Requirements

Reporting into the Senior Director, Biostatistics this position is responsible for:

  • Global management of statistical activities in Recombinant & Gene Product Development (RGPD).
    • Align priorities of non-clinical statistics with R&D project priorities
    • Manage resources and project timelines
    • Ensure quality of statistical deliverables and compliance with regulations
    • Strive to establish work processes and procedures for pre-clinical statistics
  • Lead the statistical and quantitative methods development in PD
    • Provide statistical expertise to pre-clinical R&D teams. Actively engage PD customers and translates their present and future needs into short- and long-term action plans.
    • Oversee and provide support in statistical methodology for experimental design (e.g. DoE); data analysis; interpretation of results, report generation and other documentation as required for:
      • Stability studies in accordance with international guidelines 
      • Assay development and validation; including replication strategies
      • Bioprocess development, optimisation and validation
      • Methodology for statistical process control, specification setting, tech transfer or validation
      • Lead interactions with regulatory agencies as the in-house statistical expert
    • Conduct statistical training through documentation, presentations and working closely with scientific groups, to raise awareness of statistical aspects and regulatory requirements in RGPD and to raise basic competence in use of standard platforms (e.g. R, JMP, PLA by Stegmann Systems)
    • Promote the cultural & mindset shift towards Digital Innovation, value creation and support the establishment of a Data Ownership Mindset
    • Actively engage with external collaborators both commercial and academic to ensure that CSL RGPD is current with methods and areas relevant to its business – e.g. methods for handling big data. Manage contractors and/or CROs as needed.

To be successful in this position, you will have:

  • PhD in Statistics, Biostatistics, Computer Sciences or equivalent experience
  • 8+ years’ experience with proven technical ability and data analysis for process development or manufacturing support. Possesses knowledge and experience in design of data analytics systems in similar industry.
  • Experience in pre-clinical statistical setting involving development, validation and analysis of biological assays, experimental design and analysis, and general statistical consulting preferable
  • Experience in Quality by Design topics in biopharmaceutical development and manufacturing.
  • Solid understanding of statistical principles and methods applicable to the product development setting, e.g. experimental design and analysis, random sampling, validation and optimisation.
  • Preferable hands-on analytical skills in predictive and prescriptive modeling, machine learning, data mining and optimization algorithms
  • In additional to strong fundamental statistical techniques, expertise in the following areas is highly regarded:
    • Hierarchical modelling
    • High dimensional data
    • Bayesian method
    • Classical and Industrial experiment designs
    • Quality control
    • Expertise with validated software such as PLA
  • Strong leadership skills; able to communicate goals, motivate teams, coach and develop talent

To Apply:

Applications must address the selection criteria above and include a current CV and covering letter.

Applications Close 21 November 2021

CSL is an Equal Opportunity Employer

Job Information

  • Job ID: 59523149
  • Location:
    Victoria
  • Position Title: Associate Director, Biostatistics
  • Company Name: CSL
  • Industry: Biostatistics
  • Job Function: Biometrics/biostatistics
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Ph.D.
  • Min Experience: 5-7 Years
  • Required Travel: 0-10%
  • Salary: 150,000.00 - 170,000.00 Australian Dollars (Yearly Salary)

Please refer to the company's website or job descriptions to learn more about them.

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