Senior Director, Biostatistics

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 18%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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ProKidney Corp.

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2015

🏥 Santé

🧬 Biotechnologie

⚕️ Assurance santé

Healthcare • Biotechnology • Healthcare Insurance

ProKidney Corp. est une entreprise de biotechnologie au stade clinique avancé, spécialisée dans la thérapie cellulaire comme traitement pour la maladie rénale chronique (MRC). Leur approche innovante vise à transformer les options thérapeutiques disponibles pour les formes avancées de MRC en préservant la fonction rénale, potentiellement en retardant ou éliminant le besoin de dialyse. En se concentrant sur un domaine où les besoins médicaux non satisfaits sont élevés, le candidat en thérapie cellulaire de ProKidney, rilparencel, est à la pointe des études cliniques pour fournir des solutions alternatives aux patients dont les options de traitement sont limitées. L'entreprise s'engage à faire progresser sa gamme de produits par le biais de développements cliniques et réglementaires et participe activement à des conférences sur la santé pour mettre en lumière son travail révolutionnaire dans le traitement de la MRC.

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.

🎯 Exigences

• 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.