CSL Plasma Inc.
Principal Biostatistician X2
CSL Plasma Inc., King Of Prussia, Pennsylvania, United States, 19406
Principal Biostatistician X2 page is loaded## Principal Biostatistician X2locations:
Americas, US-PA, King of Prussia, CSL Behringtime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: November 14, 2025 (13 days left to apply)job requisition id:
R-263505CSL'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.You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables**Main Responsibilities:**Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)Be responsible for interpreting analysis results and ensuring reporting accuracy.Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.Be accountable for the TFL/CDISC package for study report and regulatory submission.Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations**Qualifications and Experience Requirements:*** PhD or MS in Biostatistics, Statistics* 7+ years or relevant work experience* Experience with CROs (either managing a CRO, or having worked in a CRO)* Experience providing statistical leadership at a study level* Demonstrated statistical contribution in facilitating and optimizing clinical development## #LI-HYBRID## **Our Benefits**CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.Please take the time to review our to see what’s available to you as a CSL employee.## **About 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, . Our parent company, , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.## **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 .## **Do work that matters at CSL Behring!**locations:
2 Locationstime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: November 14, 2025 (13 days left to apply) #J-18808-Ljbffr
Americas, US-PA, King of Prussia, CSL Behringtime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: November 14, 2025 (13 days left to apply)job requisition id:
R-263505CSL'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.You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables**Main Responsibilities:**Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)Be responsible for interpreting analysis results and ensuring reporting accuracy.Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.Be accountable for the TFL/CDISC package for study report and regulatory submission.Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations**Qualifications and Experience Requirements:*** PhD or MS in Biostatistics, Statistics* 7+ years or relevant work experience* Experience with CROs (either managing a CRO, or having worked in a CRO)* Experience providing statistical leadership at a study level* Demonstrated statistical contribution in facilitating and optimizing clinical development## #LI-HYBRID## **Our Benefits**CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.Please take the time to review our to see what’s available to you as a CSL employee.## **About 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, . Our parent company, , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.## **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 .## **Do work that matters at CSL Behring!**locations:
2 Locationstime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: November 14, 2025 (13 days left to apply) #J-18808-Ljbffr