[Hiring] Senior Director, Biostatistics @ProKidney

Role Description

ProKidney is seeking a Senior Director, Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This highly visible, hands-on role requires a technically strong statistician who can operate strategically while remaining close to the work.

• Lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data.
• Support regulatory interactions, topline readout, and future submission activities.
• Bring deep statistical expertise, strong drug development judgment, and FDA-facing experience.
• Collaborate effectively across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.

Qualifications

• Advanced degree in Statistics, Biostatistics, Mathematics, or related field; Ph.D. preferred.
• Minimum of 10 years of pharmaceutical and/or biopharma industry experience.
• Formal education in statistics, biostatistics, or the mathematical sciences.
• Experience leading and reading out late-stage programs.
• Broad clinical trial expertise.
• Strong statistical academic background and knowledge of quantitative methods.
• Proficiency in SAS, R, Python, or related data analysis languages.
• Experience with study design and data analysis from various 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 (e.g., Word, Excel, PowerPoint).
• Excellent interpersonal, communication, writing, and organizational skills.
• Excellent analytical skills to filter, prioritize, and validate complex material.
• Proven ability to meet strict deadlines.
• Excellent organizational skills and time management.
• Attention to detail and accuracy maintaining consistently high quality.
• Self-motivated with the ability to establish and maintain effective working relationships.

Requirements

• Accountable for all biostatistics elements feeding into a BLA, such as the integrated safety summary.
• Provide hands-on statistical leadership for study design, statistical analysis plans, data interpretation, reporting, and regulatory deliverables.
• Key member of the cross-functional core study team representing biostatistics interests.
• Oversight of all external vendors, such as WCG for the Endpoint Adjudication committee and Icon for Central Laboratory.
• Accountable author of the statistical analysis plan, tables, listings, figures shells, and subsequent documentation.
• Provide statistical leadership for complex issues including randomized versus treated populations.
• Lead trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
• Generate statistical models to improve methods of evaluating quantitative and qualitative data.
• Support FDA-facing discussions and advocate for appropriate analytical approaches.
• Provide ad hoc data-driven analyses.
• Independently research, propose, teach, and implement advanced statistical analyses.
• Accountable for biostatistics SOP development and maintenance.
• Contribute to executive-level program updates, including biweekly interactions with senior leadership.

Benefits

• Equal employment opportunity employer; does not discriminate against any applicant.
• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.