Senior Biostatistician

About the job

As a Senior Biostatistician, you will contribute statistical input towards experimental designs, statistical analyses, and reporting of research studies, to ensure efficient use of resources and conclusions and deliveries following regulatory requirements and guidelines at Bern Research site. You will oversee statistical design and analysis routines in experiments that translate development strategies into plans to support product development goals, including process control and validation strategies. You will also provide statistical advice for contacts with regulatory agencies for pre-clinical Research related issues, contribute statistical input for regulatory filings for product approvals, for on-market support, and for scientific publications. A part of your job will also be the coordination with other global data analysis/computational experts (Data Management, Bioinformatics, PK/PD/Pharmacometrics and Clinical teams) to ensure that CSL Research is current and compliant in statistical methods. You will engage and work with CROs to ensure statistical analysis deliverables. Contribute statistical input to external research collaborations with academic partners. You will also provide statistics training for scientific staff and keep raising and maintaining basic competence around data analysis literacy and the use of standard statistical software (e.g., Prism, SAS JMP, and R).

Responsibilities:

• Provide statistical expertise and hands-on work to support pre-clinical Research goals at Bern site di
• Work together with other Senior Statisticians in Research to help co-ordinate the support for pre-clinical statistics tasks at Bern, Marburg, Pasadena and Melbourne sites
• Aim to establish work processes and automated routines for pre-clinical statistics
• 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 Research is current with methods and areas relevant to its business. Manage contractors and/or CROs as needed.

Your skills and experience:

• Advanced degree (Ph.D. or MSc) in Statistics or Biostatistics
• 2+ years of experience working in biotechnology or pharmaceutical setting or statistical consulting experience
• Experience with foundational statistical principles and methods applicable to the pre-clinical research setting, e.g., experimental design, randomization, statistical analysis of observational studies and liaison with clinical statisticians.
• Experience in biological assay development, validation, and analysis
• Working knowledge of R and understanding of basic programming concepts
• Strong communication skills (verbal and written in English) bridging scientific and business needs