Director/Sr. Director, Biostatistics

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