Director/Associate Director Biostatistics

Skip to main content Director/Associate Director Biostatistics Tyra Biosciences United States Apply Director/Associate Director Biostatistics Tyra Biosciences United States 1 week ago 52 applicants See who Tyra Biosciences has hired for this role Apply Save Join or sign in to save this job Join to save Director/Associate Director Biostatistics at Tyra Biosciences Email or phone Password Show Forgot password? Sign in Sign in with Email or New to LinkedIn? Join now By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy. Report this job Tyra Biosciences, Inc. is seeking a highly motivated Associate Director or Director, Biostatistics to make impactful contributions to oncology and rare disease drug development programs targeting areas of high unmet medical need. The successful candidate will be highly organized, self-motivated, and thrive in a dynamic, cross-functional, start-up environment.This role will drive the development and implementation of statistical strategies to support clinical development and will contribute to company success through robust study design, clear interpretability of results, effective regulatory support, and the application of innovative methodologies to enhance the efficiency and quality of clinical programs.Job Responsibilities· Provide statistical leadership for one or more clinical development programs from Phase 1 through Phase 3· Lead the design of clinical trials, including protocol development, endpoint selection, and sample size determination, with consideration for small populations and pediatric study constraints· Develop and implement innovative and efficient statistical methodologies tailored to rare disease and growth disorder studies, including adaptive and model-informed approaches· Author and oversee statistical sections of key regulatory documents, including protocols, Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and regulatory briefing packages· Ensure high-quality statistical deliverables, including tables, figures and listings (TFLs), and support interpretation of study results· Serve as the primary statistical representative on cross-functional teams, collaborating closely with Clinical Development, Clinical Operations, Regulatory Affairs, and Data Management· Provide strategic input on development plans, including extrapolation strategies, use of external or historical controls· Oversee CROs and external vendors to ensure timely, high-quality execution of statistical analyses· Support regulatory interactions with agencies such as the U.S. Food and Drug Administration· Contribute to publications, scientific presentations, and external communications of clinical data· Mentor and provide technical guidance to programmersWork Experience and Educational Requirements:· Ph.D. (strongly preferred) or M.S. in Statistics, Biostatistics, or a related field with 8+ years of relevant drug development experience· Demonstrated experience in oncology, pediatrics, rare disease, or growth disorders strongly preferred· Broad knowledge of statistical...