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Senior Director, Biostatistics and Data Science
2 months ago
Kyverna Therapeutics, Inc. is a pioneering biopharmaceutical company dedicated to developing innovative cell therapies for patients suffering from autoimmune diseases. As a Senior Director, Biostatistics and Data Science, you will play a critical role in shaping the company's clinical development strategies and ensuring the success of our global clinical trials.
Key Responsibilities- Strategic Leadership: Provide expert guidance on biostatistics and data science for global clinical development, creating and implementing biostatistics standards that drive short-term and long-term planning.
- Statistical Analysis Execution: Collaborate with cross-functional teams to design, execute, and analyze complex clinical studies, generating high-quality statistical methods and results for study reports and contributing to data interpretation and decision-making processes.
- Data Collection and Design Support: Offer guidance on data collection, design, and analysis for global studies, ensuring efficient medical and safety data review and monitoring, including DSMB meetings.
- Clinical Studies Management: Work closely with CROs to plan, monitor, and analyze global clinical studies, coordinating the development and review of statistical aspects of regulatory submissions.
- Clinical Development and Regulatory Interaction: Provide biostatistical input for overall clinical development strategies, protocol design, statistical analysis plans, and regulatory interactions, handling briefing books, submissions, and addressing requests and positions from regulatory agencies.
- Clinical Study Documentation Preparation: Prepare clinical study documents for eCTD clinical modules, familiar with CDISC standards, IWRS, SDTM, ADaM Specs, and review define documents.
- Development and Commercialization Support: Contribute statistical expertise to support development and commercialization strategies, including post-hoc analyses and interpretation of results.
- Cross-Functional Collaboration: Work closely with global medical, clinical operations, regulatory, and safety teams to ensure efficient execution of global clinical trials.
- Ph.D. degree in Biostatistics, Statistics, or related field.
- At least 10 years' experience in biostatistics in clinical trials across different therapeutic indications, with in-depth experience in interaction with regulatory agencies, preferably in immunology and neurology. Successful submission a plus.
- Extensive experience collaborating with scientific teams to design robust and complex clinical trials with proven success in accelerated approval.
- Proficiency in using statistical software such as R, SAS for data analysis and modeling, familiar with a variety of power calculation settings, and hands-on experience in generating TFLs.
- Familiarity with complex and novel statistical methods that apply to applicable clinical trials, such as adaptive Bayesian design, counterfactual design in RWD.
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail.
