With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
This role will be the statistical lead for Clinical Serology, a key statistical resource for discovery research and a member of the Data Science Center of Excellence with interfaces across the related Research and Development functions. This cross-functional group has members across Biostatistics, Data Management, Programing and Medical Writing. Integration within this team allows for greater impact across the company. The incumbent will be responsible for ensuring a consistent statistical approach to clinical assay validation that meets regulatory requirements by providing the statistical strategy, guidance and hands on support for clinical assay development and validations at Seqirus and contract testing facilities. In addition, as time permits, the incumbent will provide statistical guidance and support for the development of research assays. Their efforts will drive strategy for successful clinical testing and will be instrumental for the successful growth of the Clinical Serology Group. They will support bridging Research immunological assay development to Clinical Serology validatable assays. They will interact directly with regulatory agencies to represent Seqirus’ statistical strategies for assay development and to solve key programmatic issues that would affect licensure.
- Lead strategic approaches to statistical plans for assays that define key clinical trial success/failure endpoints.
- Provide technical statistical expertise and guidance for clinical assay validation, including reagent qualification, and testing whether at Seqirus or a contract laboratory. Perform statistical analyses or author/review statistical sections of project reports or key regulatory filings to agencies around the world (FDA, EMEA, TGA, etc.).
- Provide strategic oversite of clinical serology statistical approaches to ensure consistent approaches are applied across assays, facilities and programs by liaising with internal clinical teams and statisticians as well as external contract clinical testing laboratories. Key aspects involving balancing expectations and needs of internal customers (Clinical, Regulatory, Operations, Research) with the capabilities and methods available at a series of independent, external contract clinical testing laboratories. Efforts will include both work for late stage programs, but also the statistical design and analysis plan required for bridging Research designed assays that are to be used in the Proof-of-concept clinical setting.
- Lead clinical assay statistical discussions with key internal stakeholders (Clinical, Operations, Regulatory, Research) to assure experimental designs are setup properly and clinical testing strategies will support their relevant endpoints. Similar essential interactions will also be needed for external stakeholders (FDA, EMEA, TGA) where results will support licensure. From time to time, these discussions may include senior leadership (SQLT) to drive programmatic company decisions.
- Act as the clinical serology statistical resource to provide training and guidance on the application of basic statistical methodology to members of R&D. As the key statistical assay related resource, guidance will be specifically provided for new assays designed in Research intended for use in Proof-of-Concept human clinical trials.
- Maintain comprehensive knowledge and awareness of developments and trends in statistics and regulatory requirements in relation to the statistical methods applicable to assay development and validation
- Master's in Statistics and 5+ years experience OR PhD in Statistics with 3+ years in industry providing statistical support; preferably for assay development and validation
- Requires in-depth conceptual and practical expertise in biostatistics; preferred to have related experience applied to assay development and validation
- Excellent communication skills both verbally and written; able to explain complex, technical analyses to non-experts
- In depth GLP understanding and experience
- Creativity and the ability to generate accurate and reproducible results along with multi-tasking and working effectively in a fast-paced environment are critical.
- Ability to generate written reports or publications, to prepare and present data at cross-functional meetings and to internal and external stakeholders, and to demonstrate ownership, understanding, and accountability of assigned projects.
- Demonstration of intellectual and scientific curiosity, a high level of engagement, and initiative to conduct literature review to improve personal understanding and to troubleshoot & advance projects.