CSL
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Principal Biostatistician
role at
CSL . CSL 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 job is in our King of Prussia, PA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. 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
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. Required Skills
Statistical analysis and methodologies. Clinical trial design and execution. Regulatory submission processes. Seniority level
Associate Employment type
Full‑time Job function
Research #LI-HYBRID Referrals increase your chances of interviewing at CSL by 2x.
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Principal Biostatistician
role at
CSL . CSL 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 job is in our King of Prussia, PA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. 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
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. Required Skills
Statistical analysis and methodologies. Clinical trial design and execution. Regulatory submission processes. Seniority level
Associate Employment type
Full‑time Job function
Research #LI-HYBRID Referrals increase your chances of interviewing at CSL by 2x.
#J-18808-Ljbffr