4 February 2020
Applications close: 4 March 2020
We have an opportunity available for a Senior Manager, Biostatistics to join our Research team at CSL. In this senior-level role, you will lead a global team of Biostatisticians and provide statistical oversight for Research and Recombinant Product Development (R&rPD) Departments.
Reporting into the Head of Data Science, you will contribute statistical input towards experimental designs of animal and human studies, hands-on statistical analyses, interpretation and reporting of research studies, in order to ensure efficient use of resources as well as robust conclusions and deliveries following regulatory requirements and guidelines.
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.
Key Responsibilities Include:
- Global management of biostatisticians in pre-clinical R&rPD, and provision of statistical overview together with the team.
- Provision of statistical expertise to support pre-clinical R&rPD objectives:
- 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, development and validation
- Bioprocess development, optimisation and validation
- Biomarker development, validation and optimisation
- Exploratory biomarker studies and interpretation in FIH clinical studies
- Methodology for statistical process control, specification setting, tech transfer or validation
- Genomic data analysis
- Provide statistical expertise for scientific publications
- Support interactions with regulatory agencies
- Conduct statistical training for CSL R&rPD staff to raise awareness of statistical aspects and regulatory requirements in R&rPD and to raise basic competence in use of standard platforms (eg Prism, R, and Electronic Lab Notebook)
- Manage the non-clinical statistics function in Development
- Support the research Data Management function towards its goal to increase data integrity and data standards across CSL Research.
- Actively engage with external collaborators both commercial and academic to ensure that CSL R&D is current with methods and areas relevant to its business – e.g. methods for handling big data. Manage contractors and/or CROs as needed.
Skills and Experience Required:
- PhD in Statistics, Biostatistics, or equivalent experience
- Bachelor’s degree in Mathematics/Statistics or Applied Mathematics/Statistics
- Demonstrated experience in a leadership role
- Experience in pre-clinical statistical setting involving development, validation and analysis of biological assays/biomarkers, experimental design and analysis, and general statistical consulting preferable.
- Solid understanding of statistical principles and methods applicable to the pre-clinical research setting, e.g. experimental design and analysis, random sampling, validation and optimisation.
- Strong interpersonal and communication skills (verbal and written in English) bridging scientific and business needs
- Ability to build partnerships and collaborative environment
- Excellent time management and multi-tasking skills
- Strategic thinker with excellent problem solving and decision-making skills
Due to the global nature of this position, a willingness to adopt flexible working hours and travel is expected.
Applications must address the selection criteria above and include a current CV and covering letter.
Applications close March 4th, 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
Please apply via this link: Senior Manager, Biostatistics