Job description
About the Company
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We are fundamentally changing the way patients are treated for urologic cancers.
Watch our New Horizons in Bladder Cancer event and discover why it’s an exciting time to join UroGen® Pharma. Join us and be part of the team that will redefine the future of urological cancer treatment. Behind every UroGen innovation is the inspiration to empower uro-oncology patients with life-changing treatments.
At UroGen, our people are our greatest asset. We cultivate a culture built on collaboration, creativity, and continuous growth. UroGen is a dynamic, rapidly expanding organization with an unwavering focus on improving the lives of patients because they deserve better.
Reporting Manager: Executive Director, Biometrics Development
Location: Princeton, NJ
Job Summary: The Director of Biostatistics will provide scientific and operational leadership for biostatistical activities supporting assigned clinical studies and programs across UroGen’s development portfolio. This role is responsible for high-quality statistical input into study design, protocol development, analysis planning, interpretation of results, and clinical study reporting. The Director partners closely with cross-functional study teams and Biometrics colleagues to ensure timely, compliant, and decision-oriented delivery of statistical contributions.
This role is suited for an experienced statistician who can independently lead study-level statistical strategies and execution, contribute to regulatory deliverables, and collaborate effectively across functions.
Job requirements
- Ph.D. or M.S. in Biostatistics, Statistics, or related quantitative field.
- Approximately 8+ years of relevant experience in pharmaceutical or biotechnology clinical development, with increasing responsibility in study-level statistical leadership.
- Strong knowledge of clinical trial methodology, statistical principles, and practical application across one or more phases of development.
- Experience serving as lead statistician for clinical studies, including protocol input, SAP development, analysis oversight, interpretation, and reporting.
- Experience in oncology and/or specialty therapeutics clinical development.
- Working experience supporting regulatory submissions and/or agency interactions through preparation or review of statistical content.
- Proficiency in statistical programming concepts and ability to work effectively with programmers using tools such as SAS and/or R.
- Strong working knowledge of CDISC standards (SDTM/ADaM) and expectations for data quality in regulated environments.
- Strong communication, collaboration, project management, and organizational skills, with the ability to manage multiple priorities and explain complex statistical concepts clearly.
Preferred Qualifications: - Experience overseeing external statistical programming or biometrics vendor deliverables at the study level.
- Familiarity with additional analytics tools such as Python.
- Experience with or interest in AI-enabled methods relevant to clinical development, with understanding of appropriate use in regulated settings.
- Experience with adaptive or innovative trial designs, precision medicine approaches, or complex endpoint strategies.
- Specific experience in urologic oncology.
- Scientific publication or conference presentation experience.
Job responsibilities
- Provide biostatistics leadership for assigned clinical studies and support program-level activities as needed, ensuring scientific rigor, fit-for-purpose analyses, and timely delivery of statistical contributions.
- Serve as the lead biostatistician on cross-functional study teams, translating quantitative findings into clear and actionable development insights.
- Contribute to clinical trial design, protocol development, endpoint/estimand definition, sample size considerations, and statistical analysis plan development.
- Lead review and interpretation of statistical outputs; support development of clinical study reports, abstracts, presentations, and other study-level deliverables.
- Collaborate with statistical programming, data management, medical, clinical operations, regulatory, and medical writing colleagues to ensure aligned execution of biometrics deliverables.
- Support regulatory submission activities and health authority responses by preparing and reviewing study-level statistical content and rationale.
- Provide oversight and accountability of study-level vendor deliverables, as applicable, including review of quality, timelines, and issue escalation in partnership with Biometrics management.
- Ensure compliance with relevant regulatory guidance, internal standards, and data quality expectations, including CDISC-aligned outputs where applicable.
- Identify opportunities to improve efficiency, quality, and consistency in biostatistics workflows and contribute to implementation of process improvements.
- Mentor junior team members / interns and contribute technical expertise to the broader Biometrics function, without primary responsibility for formal people management.
Job benefits
We offer a competitive salary, employee benefits, and an excellent work environment.- Medical
- Dental
- Vision
- 401k Match
- Paid Time Off
- Employee Assistance Program
We are an Equal Opportunity Employer