Principal Biostatistician

CSL; King of Prussia (PA); On-site; USD 150,000 - 210,000; Full time

Job summary

CSL Behring in King of Prussia, PA / Waltham, MA is seeking a Principal Biostatistician to lead statistical contributions in a clinical development program. The role blends statistical strategy with regulatory submissions, requiring collaboration across teams and external partners.

You will oversee study design, analysis, and reporting, ensure quality deliverables, and partner with CROs to manage timelines and outsourcing.

Qualifications

• PhD or MS in Biostatistics or Statistics.
• 7+ years in pharma industry or CRO.
• Experience leading statistical contributions at the study level.

Responsibilities

• Input to statistical strategy and ensure applicable methodologies for trials and regulatory submissions.
• Lead Biostatistics conduct in study design, data collection, analysis, reporting, and submission.
• Author the initial statistical analysis plan for trials and regulatory submissions.
• Coordinate with regulatory authorities (FDA/EMA/PMDA) as needed.

Skills

Statistical leadership

Clinical trial statistics

CRO management

Regulatory submissions

Education

PhD or MS in Biostatistics

Job description

## Principal BiostatisticianPresenta candidaturalocations: Americas, US-PA, King of Prussia, CSL Behringtime type: Full timeposted on: Offerta pubblicata oggijob requisition id: R-282817CSL'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.Could you be our next Principal Biostatistician? **The role is based in our King of Prussia, PA or Waltham, MA locations. This is a hybrid position and is onsite a minimum of 3 days per week.****Position Purpose:**You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician will implement statistical strategies for 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 **Minimum Qualifications and Experience Requirements:*** PhD or MS in Biostatistics, Statistics* 7+ years or relevant work experience in the pharmaceutical industry and/or CRO* Experience 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**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.