Lead biostatistical strategy and execution for a pivotal Phase 3 program, including study design, analysis plans, data interpretation, reporting, regulatory submissions, and FDA interactions. Oversee biostatistics vendors, develop SOPs, support BLA activities, conduct advanced analyses, and communicate study risks and milestones to executive leadership. Collaborate cross-functionally across clinical development, regulatory, data management, pharmacovigilance, quality, and data science teams.
Position Summary:
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.
The Senior Director will lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data, while supporting regulatory interactions, topline readout, and future submission activities. The ideal candidate will bring deep statistical expertise, strong drug development judgment, FDA-facing experience, and the ability to collaborate effectively across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.
Essential Duties & Responsibilities:- Phase 3 study lead; accountable for not only study read out but all biostatistics elements that will subsequently feed 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 who represents the interests of the biostatistics deliverables while overseeing the overall study conduct.
- Escalation point and oversight of all external vendors, such as WCG for the Endpoint Adjudication committee and Icon for Central Laboratory
- Functional lead of the biostatistical team
- Leader who maintains composure and creative problem solving in a flexible, fast paced
- Accountable author of the statistical analysis plan, tables listings and figures shells, and subsequent documentation
- Provide statistical leadership for complex issues including randomized versus treated populations
- Leads trial design, protocol development, analysis planning, interpretation of results and preparation of regulatory submissions
- Generates statistical models to improve methods of evaluating quantitative and qualitative data, identifying relationships and trends in data and factors affecting research results.
- Support FDA-facing discussions and help advocate for appropriate analytical approaches in a complex and differentiated therapeutic setting.
- Provides ad hoc data driven analyses
- Independently research, propose, teach and implement advanced statistical analyses
- Accountable and responsible for biostatistics SOP development and maintenance
- Contribute to executive-level program updates, including biweekly interactions with senior leadership regarding study progress, key risks, upcoming milestones, and decision points.
- Education/Training:
- Advanced degree in Statistics, Biostatistics, Mathematics, or related Ph.D. preferred.
- Minimum of 10 years of pharmaceutical and/or biopharma industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus).
- Formal education in statistics, biostatistics or the mathematical sciences
- Experience leading and reading out late stage programs
- Broad clinical trial expertise
- Must have 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 (e.g., Word, Excel, Powerpoint).
- Must have excellent interpersonal, communication, writing and organizational
- Must have excellent analytical skills in order to filter, prioritize and validate potentially complex and dynamic material from multiple sources.
- Proven ability to meet strict
- Excellent organizational skills and time management
- Excellent attention to detail and accuracy maintaining consistently high-quality
- Self-motivated and
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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