Senior Statistician

Senior Statistician

Csl Plasma

Senior Statistician

Details of the offer

The Opportunity:

CSL has an exciting opportunity available for a Senior Statistician to join our Recombinant & Gene Product Development (RGPD) in Parkville. The Senior Statistician is responsible for providing hands-on statistical support and technical guidance for global RGPD departments. This role will work in a highly interdisciplinary environment, establishing and leading standardised approaches to work processes and procedures for pre-clinical statistics. The incumbent will actively drive statistical activities and project timelines, in order to ensure robust conclusions following regulatory requirements and guidelines.
This individual will participate in the design, development and quality control process of statistical workflows, in order to standardise access, extraction, transformation, review, analysis and submission of pre-clinical data for all requested analyses. This individual will interface with other CSL departments and functional areas of global Recombinant & Gene Product Development (e.g. Quality, Analytics, Formulation, Upstream Development and Downstream Development) to ensure a strong understanding of bioprocess development..
As a senior member of the team, this individual will participate in departmental and cross functional technology development and process improvement initiatives.
Reporting into the Associate Director of Statistics, Recombinant & Gene Product Development, this position is responsible for:
Provision of statistical expertise to support non-clinical RGPD objectives.
Application of sound methodologies for statistical analysis in RGPD in accordance to the regulatory guidelines.
Development of statistical and quantitative methods in RGPD.
Proactively identify opportunities for new application of key statistical concepts to RGPD workflows.Statistical process control
Linear and nonlinear model building
Exploratory data analysis and data visualization

Actively engage customers and translates their present and future needs into short- and long-term action plans.
Establish work processes and procedures for pre-clinical statistics
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
Biomarker development, optimisation and validation
Methodology for statistical process control, specification setting, tech transfer or validation

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)
Actively engage with external collaborators both commercial and academic to ensure that CSL RGPD is current with methods and areas relevant to its business.

To be successful in this position, you will have:

A Masters qualification in Statistics, Biostatistics, Computer Sciences or equivalent experience. PhD candidates are strongly encouraged to apply.
5+ years' experience, preferable in pharma industry, with proven technical ability and data analysis for process development or manufacturing support.
Advanced to expert programming skills inat least oneof; Python, R, MATLAB, JSL/SAS.
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.
Strong analytical thinking with the ability to comprehend scientific data, apply appropriate statistical methodology and interpret and convey the outcome to technical and non-technical audience(s).
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 by Stegmann Systems

Influential in interactions with key business contacts (internal and external)
Excellent oral and written communication skills
Strategic thinker with excellent problem solving and decision-making skills.

To Apply:
Applications must address the selection criteria above and include a current CV and covering letter.
Applications close May 31st, 2020
Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability
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