CSL
Principal Biostatistician X2
– Location: King of Prussia, PA (Hybrid, onsite three days a week). You will report to the Director of Biostats.
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.
Responsibilities
Input to statistical strategy and ensure appropriate statistical methodologies are 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 analysis plan.
Support biostatistics interactions with regulatory authorities (e.g., 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 and conduct reviews of deliverables.
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 or Statistics.
7+ years of 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.
Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day one. Our benefits support the needs of employees at every stage of life, including health care, financial resources, and wellness programs.
About CSL Behring CSL Behring is a global biotherapeutics leader focused on saving lives. We deliver innovative therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas using platforms such as plasma fractionation, recombinant protein technology, and cell and gene therapy.
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– Location: King of Prussia, PA (Hybrid, onsite three days a week). You will report to the Director of Biostats.
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.
Responsibilities
Input to statistical strategy and ensure appropriate statistical methodologies are 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 analysis plan.
Support biostatistics interactions with regulatory authorities (e.g., 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 and conduct reviews of deliverables.
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 or Statistics.
7+ years of 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.
Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day one. Our benefits support the needs of employees at every stage of life, including health care, financial resources, and wellness programs.
About CSL Behring CSL Behring is a global biotherapeutics leader focused on saving lives. We deliver innovative therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas using platforms such as plasma fractionation, recombinant protein technology, and cell and gene therapy.
#J-18808-Ljbffr