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!
We have an exciting opportunity for a Senior Biostatistician who will be a key member of the Biostatistics, Data management, Medical Writing and Programming (BDMP) group with interfaces across the Research and Development functions. The Senior Biostatistician delivers scientific excellence to clinical vaccine development and will be responsible for providing statistical expertise and leadership for clinical assay development , validation and life-cycle of clinical assays within the organization and contract testing facilities.
The jobholder will drive the statistical strategy for the development, validation and maintenance of assays supporting clinical testing, experimental design for the research. The incumbent will deliver statistical expertise that will be used to deliver fit-for-purpose solutions, keep the methodologies up to date and aligned with guidance. Furthermore, the incumbent will provide statistical expertise, leadership and guidance for bridging Research immunological assay development to Clinical Serology validated assays. They will interact with external key opinion leaders as the recognized company statistical expert for the design, analysis and reporting of assay validations.
- Serves as a SME and lead biostatistics contributions to, and facilitate the direction of robust clinical development planning, seamlessly integrating all relevant technical and indication-specific knowledge
- Provides statistical scientific consulting, and quantitative contributions to planning, execution and reporting of clinical trials and regulatory/submission strategy and related documents: (e.g.: SAP, Protocol, CSRs, integrated summaries, and responses to HA questions).
- Actively participates in the SET/CDT (or equivalent) to provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximise probability of program success with objective and transparent clinical program assessments using quantitative risk/probability of success assessments.
- Oversee production of, contribute to or prepare statistical sections of protocols, statistical analysis plans and CSRs. Generate and/or verify sample size calculations and randomization schemes as needed. Perform quality control checks of statistical analyses and SAS programs, as needed. Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
- Provide technical statistical expertise and leadership within the framework of the indication. Analyse data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
- Collaborate with, direct and monitor the work of CRO / statistical programming/ external consultants. Support and develop the relationships with CROs statistical functions. Perform acceptance checks of CRO/internal deliverables. Responsibility for statistical parts of CRO tendering process and work orders involving assigned therapeutic area.
Skills, Experience and Qualifications:
- Advanced degree (PhD, or MS) in Statistics/Biostatistics (or equivalent).
- At least 6 years of experiences in Clinical Development in a Pharmaceutical or Biotech
- Knowledge of SAS/R and various sample size calculation software
- Strong Technical statistical expertise and leadership within the framework of the indication.
- Comprehensive understanding of study design and regulatory requirements necessary to deliver with high quality and on time.
- Effective delivery of objectives in a complex matrix environment.
- Ability to deal with rapid change.
- Effective verbal & written communication skills in a cross functional environment.
- Attention to detail.
- Excellent project management skills.
- Proactively owns and drives assigned tasks to completion.
- Proactively develops solutions to complex issues.
- Develops effective contingency plans.
- Good negotiation skills with internal and external stakeholders.
- Demonstrated ability to take measured risks with overall positive outcome for the business,
- Desirable to have an understanding of epidemiology, modern clinical safety and pharmacovigilance, pharmacokinetics and dynamics, assay development and validation