The Sr. Manager, Biostatistics leads statistical activities for clinical studies, ensuring quality deliverables and compliance with regulatory standards while collaborating cross-functionally and with external partners.
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.
Responsibilities
- Serve 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 results
- Execute and oversee statistical analyses, including review of tables, listings, and figures generated by internal teams or CROs
- Prepare and review statistical methods and results sections for clinical study reports and contribute to integrated analyses
- Provide statistical guidance on study design, data collection, data review, and analysis for clinical trials
- Support efficient medical and safety data review and monitoring activities, including participation in DSMB meetings as needed
- Contribute to the development and review of statistical components of regulatory submissions and responses to health authority questions
- Support protocol development, amendments, and data review meetings with cross-functional teams
- Review clinical study documentation for eCTD submissions, including familiarity with CDISC standards, SDTM, ADaM, and define.xml
- Collaborate closely with clinical operations, data management, medical, regulatory, and safety teams to support global study execution
- Contribute to continuous improvement of statistical processes
Qualifications
- Ph.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 preferred
- Demonstrated experience serving as the lead statistician for clinical studies from design through analysis and reporting
- Experience working with cross-functional clinical development teams
- Exposure to regulatory submissions and interactions with health authorities
- Proficiency in statistical software such as SAS and/or R for data analysis and modeling
- Hands-on experience generating and reviewing tables, listings, and figures
- Working knowledge of CDISC standards, including SDTM and ADaM
- Familiarity with advanced statistical methods applicable to clinical trials, such as multiple imputation or Bayesian designs and real-world data analyses
- Strong written and verbal communication skills
- Ability to work cross-functionally in a fast-paced, collaborative environment
- Strong attention to detail and organizational skills
The 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.
Top Skills
Adam
Cdisc Standards
R
SAS
Sdtm
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