Senior Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the statistical lead for ProKidney's crucial Phase 3 program.

• Direct the statistical strategy, analysis, interpretation, and reporting for intricate clinical trial data.

• Assist in regulatory interactions, topline readouts, and future submission activities.

• Take on the role of Phase 3 study lead, responsible for study readout and biostatistics elements contributing to a BLA, including the integrated safety summary.

• Offer 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 the overall study conduct.

• Manage and oversee external vendors, including WCG for the Endpoint Adjudication Committee and ICON for Central Laboratory.

• Lead the biostatistical team.

• Maintain composure and utilize creative problem-solving in a dynamic, fast-paced environment.

• Author the statistical analysis plan, tables, listings, figures shells, and subsequent documentation.

• Provide statistical leadership on complex issues, including randomized versus treated populations.

• Direct trial design, protocol development, analysis planning, results interpretation, and regulatory submission preparation.

• Create statistical models to assess quantitative and qualitative data and identify relationships, trends, and factors influencing research outcomes.

• Support FDA-facing discussions and advocate for suitable analytical approaches.

• Offer ad hoc data-driven analyses.

• Independently research, propose, educate, and execute advanced statistical analyses.

• Develop and maintain biostatistics SOPs.

• Contribute to executive-level program updates, including biweekly communications with senior leadership regarding study progress, risks, milestones, and decision points.

• Collaborate across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.

⛳️ Requirements

• An advanced degree in Statistics, Biostatistics, Mathematics, or a related Ph.D. is preferred.

• At least 10 years of experience in the pharmaceutical and/or biopharma industry, including design and analysis of clinical studies (experience with cell therapies/biologics is a plus).

• Formal education in statistics, biostatistics, or mathematical sciences.

• Experience leading and presenting late-stage programs.

• Comprehensive expertise in clinical trials.

• Strong statistical academic foundation and knowledge of quantitative methods, including predictive modeling techniques.

• Proficient in SAS, R, Python, or related data analysis languages.

• Experience with study design and data analysis across various phases of clinical development.

• Previous involvement with studies that require nontraditional treatment logistics.

• Prior experience in BLA/NDA submission planning and execution.

• Competency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).

• Exceptional interpersonal, communication, writing, and organizational skills.

• Strong analytical skills to filter, prioritize, and validate complex and dynamic material from multiple sources.

• Demonstrated ability to meet stringent deadlines.

• Excellent organizational skills and time management capabilities.

• Meticulous attention to detail and accuracy while consistently producing high-quality work.

• Self-motivated and capable of working independently.

• Ability to establish and maintain effective working relationships with colleagues, managers, and clients.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday policy.

• Retirement savings plan with company match.

• Opportunities for professional development and continuing education.