Senior Director, Biostatistics

🕒 August 19

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 24%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ProKidney Corp.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

ProKidney Corp. is a late clinical-stage biotechnology company focused on pioneering cell therapy as a treatment for Chronic Kidney Disease (CKD). Their innovative approach aims to transform the therapeutic options available for advanced CKD by preserving kidney function, potentially delaying or eliminating the need for dialysis. With a focus on an area of high unmet medical need, ProKidney's cell therapy candidate, rilparencel, is at the forefront of clinical studies to provide alternative solutions for patients with limited treatment options. The company is committed to advancing its pipeline through clinical and regulatory developments and actively participates in healthcare conferences to bring attention to its groundbreaking work in CKD treatment.

📋 Description

• Serve as the statistical lead for ProKidney's pivotal Phase 3 program. • Lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data. • Support regulatory interactions, topline readout, and future submission activities. • Serve as Phase 3 study lead, accountable for study readout and biostatistics elements feeding into a BLA, including the integrated safety summary. • Provide hands-on statistical leadership for study design, statistical analysis plans, data interpretation, reporting, and regulatory deliverables. • Represent biostatistics on the cross-functional core study team while overseeing overall study conduct. • Escalate and oversee external vendors, including WCG for the Endpoint Adjudication Committee and ICON for Central Laboratory. • Lead the biostatistical team. • Maintain composure and apply creative problem solving in a flexible, fast-paced environment. • Author the statistical analysis plan, tables, listings and figures shells, and subsequent documentation. • Provide statistical leadership on complex issues, including randomized versus treated populations. • Lead trial design, protocol development, analysis planning, results interpretation, and regulatory submission preparation. • Generate statistical models to evaluate quantitative and qualitative data and identify relationships, trends, and factors affecting research results. • 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. • Develop and maintain biostatistics SOPs. • Contribute to executive-level program updates, including biweekly interactions with senior leadership on study progress, risks, milestones, and decision points. • Collaborate across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.

🎯 Requirements

• 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. • Strong statistical academic background and 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). • Excellent interpersonal, communication, writing and organizational skills. • Excellent analytical skills to filter, prioritize and validate potentially complex and dynamic material from multiple sources. • Proven ability to meet strict deadlines. • Excellent organizational skills and time management. • Excellent attention to detail and accuracy while maintaining consistently high-quality work. • Self-motivated and able to work independently. • Ability to establish and maintain effective working relationships with coworkers, managers and clients. • Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.