Principal Biostatistician

Posted 2 Days Ago
Be an Early Applicant
27 Locations
Remote
Senior level
Biotech
The Role
Lead biostatistical strategy for preclinical and translational research, design experiments, perform analyses, support regulatory filings and publications, collaborate with cross‑functional teams (bioinformatics, PK/PD, imaging), and build external partnerships to enable clinical development.
Summary Generated by Built In

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. 

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.

Main Responsibilities:

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.​

Qualifications and Experience Requirements:

  • 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​

Are you interested? We are looking forward to receiving your online application.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.


You Belong at CSL

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.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

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 visit https://www.csl.com/accessibility-statement.

Skills Required

  • Postgraduate degree in Statistics, Biostatistics, or equivalent experience (PhD preferred)
  • Minimum of 5 years' experience in pharmaceutical or biotech R&D or equivalent academic experience
  • Proven experience working with global, cross-functional scientific teams
  • Experience designing experiments and performing statistical analyses for preclinical and translational studies
  • Experience contributing to regulatory filings, animal ethics applications, and scientific publications
  • Ability to coordinate with data managers, bioinformaticians, imaging and AI analysts, and PK/PD experts
  • Excellent communication, analytical, interpersonal, organizational skills, and ability to manage complex projects
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The Company
HQ: King of Prussia, PA
20,401 Employees

What We Do

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

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