Backed by NEA.
About the role
LeonaBio is seeking a Senior Director, Biostatistics to provide strategic and hands-on leadership across clinical development programs. Reporting to the Chief Medical Officer, this role will be responsible for shaping statistical strategy throughout the drug development lifecycle, from study design and analysis through data interpretation, regulatory submissions, and health authority interactions.
What they're looking for
- Provide statistical leadership across clinical development programs, including study design, endpoint selection, sample size and power calculations, randomization, analysis strategy, and interpretation of clinical data
- Partner with Clinical Development and other cross-functional teams on protocol development, statistical analysis plans (SAPs), study design decisions, and overall development strategy
- Lead or oversee statistical analyses and deliverables across clinical trials, including tables, listings, figures (TLFs), clinical study reports, and other key clinical and regulatory documents
- Provide statistical expertise for interim analyses, Data Safety Monitoring Boards (DSMBs), and other study oversight activities as appropriate
- Oversee external biostatistics and statistical programming partners, including CRO selection and management, scope, timelines, quality, and deliverables
- Represent Biostatistics on cross-functional program teams and serve as a trusted statistical advisor to Clinical Development, Regulatory, Data Management, Clinical Operations, Medical, and senior leadership
More about this role
About Leona
LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company developing novel therapeutics for high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS). Our lead programs, lasofoxifene and brelgometon, are novel small-molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. We are committed to scientific excellence and patient-centered innovation as we advance meaningful new therapies for patients.
Position Summary
LeonaBio is seeking a Senior Director, Biostatistics to provide strategic and hands-on leadership across clinical development programs. Reporting to the Chief Medical Officer, this role will be responsible for shaping statistical strategy throughout the drug development lifecycle, from study design and analysis through data interpretation, regulatory submissions, and health authority interactions.
The Senior Director will serve as a senior scientific partner to Clinical Development, Regulatory, Data Management, Clinical Operations, and other cross-functional teams, providing...
Browse similar: Startup jobs · Remote jobs