Sr. Director, Biostatistics

LeonaBio, Inc.; Bothell (WA); On-site; USD 270,000 - 290,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with employer match

PTO 25 days + 11 holidays

Job summary

LeonaBio, Inc. in the Seattle area is seeking a Senior Director, Biostatistics to lead statistical strategy across the drug development lifecycle.

You will partner with Clinical Development, Regulatory, Data Management, and other teams to shape study design and interpretation of results. The ideal candidate has 10+ years in biostatistics within biotech/pharma, strong expertise in oncology/neurology or related diseases, and a track record in regulatory submissions and external partner management.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years of biostatistics experience in pharma/biotech/CRO with leadership in clinical development.

Responsibilities

• Provide statistical leadership across clinical development programs including study design, endpoint selection, sample size and power, randomization and analysis strategy.
• Lead or oversee statistical analyses and deliverables across trials (TLFs, CSR, etc.) and support regulatory submissions.
• Provide statistical input for regulatory interactions and health authority questions; prepare statistical sections and briefing materials.
• Oversee external biostatistics partners/CROs and manage resources and timelines.

Skills

Biostatistics leadership

Clinical development

Regulatory submissions

Statistical design

SAS and/or R

CDISC SDTM/ADaM

Education

PhD or MS in Biostatistics

Tools

SAS

R

Job description

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 expertise in study design, statistical methodology, and interpretation of clinical data. The ideal candidate brings strong technical expertise, sound scientific judgment, and the ability to operate independently in a collaborative, fast-paced biotechnology environment.

Key Responsibilities

• 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 input and leadership for regulatory submissions and health authority interactions, including preparation of statistical sections, briefing materials, responses to regulatory questions, and meeting support.
• 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.
• Identify statistical and methodological risks and opportunities early, providing practical, scientifically rigorous recommendations to support clinical development decisions.
• Contribute to the development and maintenance of biostatistics standards, processes, and best practices, including applicable CDISC standards and statistical programming conventions.
• Communicate complex statistical concepts and clinical results clearly to both technical and non-technical audiences.
• Operate effectively in a lean biotechnology environment, balancing strategic leadership with hands-on scientific execution.

Required Qualifications

• PhD or MS in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years of biostatistics experience in the pharmaceutical, biotechnology, or CRO industry, with demonstrated experience providing statistical leadership in clinical development. Experience in solid tumor oncology highly preferred.

• Experience in oncology, neurology, neurodegenerative, or rare diseases.
• Strong knowledge of clinical trial design, statistical methodology, and drug development.
• Experience supporting late-stage clinical development and registration-enabling studies.
• Experience with regulatory submissions and health authority interactions, including INDs, NDAs, BLAs, MAAs, and/or global equivalents.
• Experience with adaptive trial designs, biomarker-driven strategies, or other innovative statistical methodologies.
• Demonstrated experience with clinical trial design, statistical analysis plans, data interpretation, and clinical study reporting across multiple development phases.
• Experience overseeing statistical programming and external biostatistics partners/CROs, including effective resource planning.
• Experience working in a lean clinical-stage biotech or pharmaceutical environment with significant use of external partnerships and functional outsourcing.
• Proficiency in statistical programming and analysis tools, such as SAS and/or R.
• Working knowledge of clinical data standards, including CDISC SDTM and ADaM.
• Strong scientific writing, communication, and presentation skills.
• Demonstrated ability to work independently, exercise sound scientific judgment, and influence cross-functional decisions in a matrixed environment.

Benefits & Perks

We offer a comprehensive benefits package designed to support our employees and their families, including:

• Medical, dental, and vision coverage: Leona covers 100% of employee premiums and 80% of dependent premiums (Premera Blue Cross PPO, Delta Dental, VSP)
• 401(k) with employer match: immediate eligibility, with Leona matching 100% of employee contributions up to 4% of salary
• Generous PTO: 25 days accrued annually, plus 11 paid holidays and a company-wide closure the last week of December
• Life & disability coverage: Basic Life, AD&D, Short-Term and Long-Term Disability fully paid by Leona, with voluntary options available
• Flexible Spending Accounts: Health and Dependent Care FSA options
• Professional development: up to $6,000 annually reimbursed for job-relevant, manager-approved education

Compensation

The base salary range for this position is $270,000-$290,000. This role may be eligible for an annual bonus and equity, in addition to our full benefits package outlined above. Actual compensation will be determined based on factors including relevant experience, skill set, education, and internal pay equity.

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual's race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.