Principal Biostatistician at CSL

Melbourne Airport, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

28 Jan, 26

Salary

0.0

Posted On

30 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Statistical Analysis, Experimental Design, Regulatory Compliance, Data Analysis, Collaboration, Communication, Project Management, Innovation, Pharmaceutical R&D, Interpersonal Skills, Scientific Reporting, Statistical Methods, Cross-Functional Teamwork, Literature Review, Scientific Publications

Industry

Pharmaceutical Manufacturing

Description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Your Opportunity As Principal Biostatistician you will provide high level expertise in the specialist area of Research Biostatistics. You will support research activities in alignment with the respective Therapeutic Area (TA) Research Strategies. In collaboration with Research teams contribute statistical input towards experimental designs, statistical analyses, interpretation and reporting of research studies, to ensure efficient use of resources as well as robust conclusions and deliveries following regulatory requirements and guidelines. The position plays a key role in executing research strategies, fostering internal and external partnerships, and ensuring delivery of impactful preclinical and translational science packages that support clinical development and business objectives. Your Responsibilities will include Functional Responsibilities Execute Biostatistics strategies aligned with global therapeutic area (TA) and platform priorities, closely collaborating with across Global Research with key connections with Bioinformatics & AI, Translational Research, Research Therapeutic area leads and research project teams Maintain relevant state-of-the-art knowledge and capabilities through literature review and participation in scientific meetings Oversee statistical design and analysis routines in experiments that translate development strategies into plans to support product development objectives, including process control and validation strategies Utilise expertise to provide statistical input towards experimental designs, statistical analyses, interpretation and reporting of research studies Provide statistical advice for contacts with regulatory agencies for pre-clinical R&D topics, e.g., in animal ethics applications Contribute statistical input for regulatory filings for product approvals, for on-market support, and for scientific publications Coordinate with other data analysis/computational experts (Data Managers, Bioinformaticians, Imaging & AI Analysts, PK/PD/Pharmacometricians, etc.) both in house and externally, to ensure that CSL R&D is current and compliant in statistical methods Scientific Innovation & Communication Provide scientific input across R&D programs, including drug discovery, in vitro pharmacology, biomarker development, and OMICS studies Execute Biostatistical pipelines to enable early decision making across research, drive efficiency and generation of high quality data Compile scientific reports, regulatory documents, and peer-reviewed publications Present research findings at internal and external meetings and maintain state-of-the-art knowledge through literature and congress participation External Collaboration & Representation Establish and maintain collaborations with academic institutions, biotech companies, CROs, and other external partners to support execution of the Research Project Portfolio. Support patent filings and legal contract negotiations in collaboration with CSL’s legal and IP departments Your skills & Experience Postgraduate degree (preferably PhD) in Statistics, Biostatistics, or equivalent experience Minimum of 5 years of experience in pharmaceutical or biotech R&D, or equivalent experience in a relevant academic environment Proven experience in working with scientific teams in a global, cross-functional environment Excellent communication, analytical, and interpersonal skills Demonstrated ability to drive innovation, manage complex projects, and translate scientific insights into strategic value High integrity, organizational skills, and a proactive, entrepreneurial mindset Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL Do work that matters at CSL! CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates

Responsibilities

As Principal Biostatistician, you will provide high-level expertise in Research Biostatistics and support research activities aligned with Therapeutic Area Research Strategies. You will collaborate with research teams to contribute statistical input towards experimental designs, analyses, and reporting of research studies.