Senior Manager, Biostatistics
Kyverna Therapeutics
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $165,000 - $190,000 per year
Job Level
About the role
- 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
Requirements
- 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
Benefits
- This position is also eligible for bonus
- benefits, and participation in Company’s stock plan.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysispower calculationssample size calculationsstatistical analysis plansCDISC standardsSDTMADaMBayesian designsmultiple imputationdata modeling
Soft Skills
strong written communicationstrong verbal communicationattention to detailorganizational skillscollaborative environmentcross-functional teamworkleadershipproblem-solvingadaptabilitycritical thinking
Certifications
Ph.D. in BiostatisticsPh.D. in StatisticsM.S. in BiostatisticsM.S. in Statistics