Senior Director, Biostatistics

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.

This position will 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 a variety of clinical studies. 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.

Responsibilities

• Strategic Leadership: Provide strategic guidance as the expert in biostatistics for global clinical development. Create and build biostatistics standard at Kyverna, including short term and long tern planning
• Statistical Analysis Execution: hands on experience on study design, power calculation, 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: Working with the CROs, 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 overall clinical development strategies, protocol design, statistical analysis plans, and regulatory interactions. Handle briefing books, submissions, and address requests and positions from regulatory agencies
• Clinical Study Documentation Preparation: Prepare clinical study documents for eCTD clinical modules. Familiarity with CDISC standards, IWRS, STDM, 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

Requirements

• Ph.D. degree in Biostatistics, Statistics, or related field
• At least 10 years’ experience, responsible for biostatistics in clinical trials across different therapeutic indications with in depth experience in interaction with regulatory agencies, preferable in immunology and neurology. Successful submission a big 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. Hands on experience currently on 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

The salary range for this position is from $240,000 - $300,000 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 option plan.

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets