Senior Director, Biostatistics

This is a fully remote position, open to applicants in Washington.

📋 Description

• Provide statistical leadership throughout clinical development programs, encompassing study design, endpoint selection, sample size and power calculations, randomization, analysis strategy, and interpretation of clinical data.

• Collaborate with Clinical Development and cross-functional teams on protocol development, statistical analysis plans (SAPs), study design decisions, and the overall development strategy.

• Lead or supervise statistical analyses and deliverables across clinical trials, including tables, listings, and figures (TLFs), clinical study reports, and other related clinical and regulatory documents.

• Offer statistical input and leadership for regulatory submissions and interactions with health authorities, including statistical sections, briefing materials, responses to regulatory inquiries, and meeting support.

• Provide statistical expertise for interim analyses, Data Safety Monitoring Boards (DSMBs), and other study oversight activities.

• Manage external biostatistics and statistical programming partners, including the selection and oversight of CROs, 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, offering practical and scientifically rigorous recommendations.

• Contribute to the development of biostatistics standards, processes, and best practices, including relevant CDISC standards and statistical programming conventions.

• Clearly communicate complex statistical concepts and clinical results to both technical and non-technical audiences.

• Balance strategic leadership with hands-on scientific execution in a lean biotechnology environment.

• Report directly to the Chief Medical Officer.

⛳️ Requirements

• PhD or MS in Biostatistics, Statistics, or a related quantitative field.

• Over 10 years of biostatistics experience within the pharmaceutical, biotechnology, or CRO sectors, showcasing a proven track record of providing statistical leadership in clinical development.

• Experience in oncology, neurology, neurodegenerative, or rare diseases.

• Strong understanding of clinical trial design, statistical methodology, and drug development processes.

• Experience supporting late-stage clinical development and registration-enabling studies.

• Familiarity 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.

• Proven experience in 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, along with effective resource planning.

• Background in a lean clinical-stage biotech or pharmaceutical setting with significant reliance on 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 skills in scientific writing, communication, and presentation.

• Proven ability to work independently, exercise sound scientific judgment, and influence cross-functional decisions within a matrixed environment.

• Solid tumor oncology experience is highly preferred.

🏝️ Benefits

• 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 during the last week of December.

• Basic Life, AD&D, Short-Term and Long-Term Disability fully covered by Leona, with additional voluntary options available.

• Flexible Spending Accounts: Options for Health and Dependent Care FSAs.

• Professional development: up to $6,000 annually reimbursed for job-relevant, manager-approved education.

• Annual bonus eligibility.

• Equity eligibility.

• Comprehensive benefits package.