Principal Biostatistician

CSL Plasma • Waltham, MA

12d • 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 Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. You will lead 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
• 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

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

Benefits

• CSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
• We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
• Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
• Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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