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CSL · 13 hours ago

Principal Biostatician

Greater Philadelphia

Full-time

Hybrid

Senior Level, Lead/Staff

7+ years exp

CSL is a biotech company focused on accelerating innovation to deliver impactful therapies for patients. The Principal Biostatistician will play a crucial role in leading statistical strategies and methodologies for clinical trials and regulatory submissions, ensuring high-quality data analysis and reporting.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

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