Sr. Director, Biostatistics

The role

The Senior Director, Biostatistics will serve as the statistical lead for a pivotal Phase 3 program. This role involves leading statistical strategy, analysis, interpretation, and reporting for complex clinical trial data and supporting regulatory interactions.

What you will do

• Phase 3 study lead accountable for study readout and biostatistics elements for BLA
• Provide hands-on statistical leadership for study design, analysis plans, and regulatory deliverables
• Represent biostatistics interests as a member of the cross functional core study team
• Provide oversight of external vendors such as WCG and Icon
• Act as functional lead of the biostatistical team
• Author statistical analysis plans, tables, listings, and figures shells
• Provide statistical leadership for complex issues including randomized versus treated populations
• Lead trial design, protocol development, and preparation of regulatory submissions
• Generate statistical models to improve methods of evaluating data
• Support FDA-facing discussions and advocate for analytical approaches

Required qualifications

• Formal education in statistics, biostatistics or the mathematical sciences
• Minimum of 10 years of pharmaceutical and/or biopharma industry experience, including design and analysis of clinical studies
• Experience leading and reading out late stage programs
• Broad clinical trial expertise
• Strong statistical academic background, knowledge of quantitative methods including predictive modeling techniques
• Proficiency in SAS, R, Python or related data analysis languages
• Experience with study design and data analysis from a range of different phases of clinical development
• Prior experience with studies involving nontraditional treatment logistics
• Prior involvement in BLA/NDA submission planning and execution
• Proficiency with Microsoft Office and web-based applications
• Excellent interpersonal, communication, writing and organizational skills
• Excellent analytical skills to filter, prioritize and validate complex material

Nice to have

• Advanced degree in Statistics, Biostatistics, Mathematics, or related Ph.D.
• cell therapies/biologics a plus

Before you apply

• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship

About the company

ProKidney is an equal employment opportunity employer.