Vice President, Biostatistics and Programming

Kezar Life Sciences is seeking a Vice President, Biostatistics and Statistical Programming to join the team. Reporting to the Senior Vice President, Clinical Development Operations, this key hire will be an inspirational and respected leader of the department. He/she is responsible for leading statistics strategy and overseeing deliverables for all programs from IND-enabling to registration and post-launch. The candidate is expected to partner closely with all key functions within clinical development, research, and business development, and provide strategic input into clinical development plan, study design, regulatory agency comments and submissions. This role requires hands-on execution as well as oversight of internal and external staff/vendors. The expectation is to be onsite at our South San Francisco, CA office at least three days per week.

Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation.

Key Responsibilities include:

• Act as the subject matter expert for Biostatistics and Statistical Programming, advising senior leadership and all stakeholders on methodologies and tools in drug development.
• Serve as the Biostatistics lead for Kezar’s oncology asset, until such time that there is a business need to hire an oncology program lead.
• Oversee the activities of internal and external staff to ensure the intended analyses are performed, and analysis data sets and their specifications are in place.
• Maintain and develop a high-performing team across the Biostatistics and Statistical Programming team.
• Based on strategic priorities, develop detail plan and priority for the department.
• Demonstrate extensive understanding of statistical concepts and methodologies. Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Provide sufficient detail to allow programming implementation. Ensure all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
• Ensure that biostats/stats programming capabilities enable the translation of corporate and clinical team objectives into operational actions, maximizing available technical platforms to assist in completing project objectives.
• Establish and meet project management requirements by incorporating cross functional processes, ensuring integration with all key functions at Kezar.
• In collaboration with Head of Clinical Data Management, ensure data collection instruments and database implementation meets project needs. Support and contribute to the establishment of data standards and its governance. Ensure accuracy and consistency of data released for statistical analysis.
• Participate in strategic planning for protocol and new program initiatives with emphasis on the statistical underpinning of study size, duration, go/no criteria, and endpoints.
• Support preparations for interactions with regulatory agencies and provide guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, briefing books, etc.).
• Ensure statistical analysis and submission datasets meet regulatory requirements.
• Ensure study results and conclusions are scientifically sound, clearly presented, and supported by statistical analysis. Provide in-depth statistical review for scientific reports and publications.
• Provide input on key document(s) development, including clinical protocols, statistical analysis plans, clinical study reports, IBs, INDs, and NDAs for all products.
• Establish and further embed SOPs, processes, and relevant quality management system strategies to ensure the department is in the state of regulatory audit-readiness.
• Provide strategic input toward data presentation for conference’s presentations and publications .
• Responsible for vendor management and performance, and key internal and vendor deliverables.
• Participates in the budget process and ongoing fiscal oversight.
• MS or PhD in statistics combined with 15+ years of proven accomplishments and growth with clinical-stage biostatistics and programming in the biopharmaceutical industry. 2+ years of leading a department.
• Preferred to have deep experience in oncology trial and CDP design, especially early deve