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The Director of Biostatistics leads statistical analysis for clinical trials, collaborates on study design, and represents biostatistics in regulatory and executive meetings.
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The Director/Sr. Director, Biostatistics will help build and lead the Biostatistical group at Kyverna Therapeutics. Working with the stats programming, clinical data management, other functional stake holders, and CROs, this position will support and oversight multiple clinical studies and development programs. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians work on the studies, ensuring individual study, the overall program and integrated analyses are delivered on time, on budget with rigor and quality.
Title: Sr./Director, Biostatistics
Reporting to: VP, Biometrics
Location: Remote
Responsibilities
- Leadership:
- Provide guidance as the expert in biostatistics for global clinical development. Create and establish biostatistics standards at Kyverna, including both short-term and long-term planning.
- Statistical Analysis Execution:
- Hands-on experience with study design, power calculation, and statistical analyses to generate tables, listings, and figures. Prepare statistical methods and results for study reports and contribute to data interpretation and decision-making processes.
- Data Collection and Design Support:
- Provide guidance on data collection, design, and analysis for global studies. Ensure efficient medical and safety data review and monitoring, including DSMB meetings.
- Clinical Studies Management:
- Collaborate with CROs to plan, monitor, and analyze global clinical studies. Coordinate the development and review of statistical aspects of regulatory submissions.
- Clinical Development and Regulatory Interaction:
- Offer biostatistical input for clinical development strategies, protocol design, statistical analysis plans, and regulatory interactions. Prepare briefing books, submissions, and respond to requests and positions from regulatory agencies.
- Clinical Study Documentation Preparation:
- Prepare clinical study documents for eCTD clinical modules. Demonstrate familiarity with CDISC standards, IWRS, STDM, ADaM specifications, and review of define documents.
- Development and Commercialization Support:
- Provide statistical expertise to support development and commercialization strategies, including post hoc analyses and result interpretation.
- Cross-Functional Collaboration:
- Work closely with global medical, clinical operations, regulatory, and safety teams to ensure the efficient execution of global clinical trials.
Qualifications
- Ph.D. degree in Biostatistics, Statistics, or a related field
- At least 15 years of experience leading biostatistics in clinical trials across multiple therapeutic areas, with in-depth experience interacting with regulatory agencies
- Proven success with regulatory submissions strongly preferred
- Extensive experience collaborating with scientific teams to design robust and complex clinical trials
- Proficiency in R and SAS for data analysis and modeling, with hands-on experience generating TFLs
- Familiarity with complex and novel statistical methods for clinical trials, such as adaptive Bayesian design and counterfactual design in RWD
- Excellent written and verbal communication skills
- Strong ability to work cross-functionally in a fast-paced, collaborative environment
- Exceptional attention to detail
The salary range for this position is from $225,000 to 290,000 annually (DOE). 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 option plan.
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