Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Sr. Manager, Biostatistics
Reporting to: Sr Director, Biostatistics
Location: Remote
Summary
The Sr. Manager, Biostatistics will provide hands-on statistical leadership and support for clinical studies. Working closely with statistical programming, clinical data management, clinical operations, and other cross-functional stakeholders, as well as external CROs, this role supports the planning, execution, analysis, and reporting of clinical trials. The Sr. Manager ensures high-quality statistical deliverables are completed on time, within budget, and in compliance with regulatory and internal standards.
ResponsibilitiesServe as the lead statistician for assigned individual clinical studies, providing hands-on support for study design, power and sample size calculations, statistical analysis plans, TFL shells, and interpretation of resultsExecute and oversee statistical analyses, including review of tables, listings, and figures generated by internal teams or CROsPrepare and review statistical methods and results sections for clinical study reports and contribute to integrated analysesProvide statistical guidance on study design, data collection, data review, and analysis for clinical trialsSupport efficient medical and safety data review and monitoring activities, including participation in DSMB meetings as neededContribute to the development and review of statistical components of regulatory submissions and responses to health authority questionsSupport protocol development, amendments, and data review meetings with cross-functional teamsReview clinical study documentation for eCTD submissions, including familiarity with CDISC standards, SDTM, ADaM, and define.xmlCollaborate closely with clinical operations, data management, medical, regulatory, and safety teams to support global study executionContribute to continuous improvement of statistical processesQualificationsPh.D. degree in Biostatistics, Statistics, or a related field and 3+ years of experience supporting biostatistics for clinical trials or M.S. degree and 6+ years of experience Experience in immunology, neurology, or rare diseases preferredDemonstrated experience serving as the lead statistician for clinical studies from design through analysis and reportingExperience working with cross-functional clinical development teamsExposure to regulatory submissions and interactions with health authoritiesProficiency in statistical software such as SAS and/or R for data analysis and modelingHands-on experience generating and reviewing tables, listings, and figuresWorking knowledge of CDISC standards, including SDTM and ADaMFamiliarity with advanced statistical methods applicable to clinical trials, such as multiple imputation or Bayesian designs and real-world data analysesStrong written and verbal communication skillsAbility to work cross-functionally in a fast-paced, collaborative environmentStrong attention to detail and organizational skillsThe California salary range for this position is from $165,000 to $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.
