Senior Biostatistician

CSL

4d • Hybrid

About The Position

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. Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Zurich Switzerland Office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. 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.

Requirements

• PhD or MS in Biostatistics, Statistics or related field
• PhD or MS with1-2 years of experience in drug development
• Advanced knowledge and training in applications of statistical methodologies in the context of clinical development

Responsibilities

• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
• Provide statistical support in data collection, data analysis, reporting, and submission preparation.
• 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.
• Support improvement initiatives and related standards for infrastructure / process / scientific consulting

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees