Job description
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.
Minimum Qualifications:
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.
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.