CSL Plasma Inc.
Senior Biostatistician page is loaded## Senior Biostatisticianlocations:
Americas, US-PA, King of Prussia, CSL Behring:
EMEA, CH, Glattbrugg, CSL Behring:
Americas, US-MA, Waltham, CSL Behringtime type:
Full timeposted on:
Posted Todayjob requisition id:
R-268709CSL'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.The Senior Biostatistician provides and may lead statistical 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.**Responsibilities:**1. Input to statistical strategy and ensure appropriate statistical methodologies applied to study
design and data analysis for clinical trials and regulatory submissions.
2 Provide statistical support in data collection, data analysis, reporting, and submission
preparation.
3 Be accountable for timely completion and quality of the statistical analysis plan.
4 Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
5 Be responsible for interpreting analysis results and ensuring reporting accuracy.
6 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.
7 Be accountable for the TFL/CDISC package for study report and regulatory submission.
8 Support improvement initiatives and related standards for infrastructure / process / scientific
consulting**Qualifications:**PhD or MS in Biostatistics, Statistics or related field
Experience PhD or MS with1-2 years of experience in drug
development
Competencies -Advanced knowledge and training in applications of statistical methodologies in the context of clinical development#LI-HYBRID## **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
and CSL Plasma at .**Our Benefits**For more information on CSL benefits visit .**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 . #J-18808-Ljbffr
Americas, US-PA, King of Prussia, CSL Behring:
EMEA, CH, Glattbrugg, CSL Behring:
Americas, US-MA, Waltham, CSL Behringtime type:
Full timeposted on:
Posted Todayjob requisition id:
R-268709CSL'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.The Senior Biostatistician provides and may lead statistical 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.**Responsibilities:**1. Input to statistical strategy and ensure appropriate statistical methodologies applied to study
design and data analysis for clinical trials and regulatory submissions.
2 Provide statistical support in data collection, data analysis, reporting, and submission
preparation.
3 Be accountable for timely completion and quality of the statistical analysis plan.
4 Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
5 Be responsible for interpreting analysis results and ensuring reporting accuracy.
6 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.
7 Be accountable for the TFL/CDISC package for study report and regulatory submission.
8 Support improvement initiatives and related standards for infrastructure / process / scientific
consulting**Qualifications:**PhD or MS in Biostatistics, Statistics or related field
Experience PhD or MS with1-2 years of experience in drug
development
Competencies -Advanced knowledge and training in applications of statistical methodologies in the context of clinical development#LI-HYBRID## **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
and CSL Plasma at .**Our Benefits**For more information on CSL benefits visit .**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 . #J-18808-Ljbffr