Senior Director, Biostatistics

Job not on LinkedIn

🔥 0 minutes ago

☕ Washington – Remote

☕ Washington – Remote

💵 $270k - $290k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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LeonaBio

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $103.5M Post IPO equity on 2021-02

Biotechnology • Pharmaceuticals • Healthcare

LeonaBio is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapies for serious diseases with limited treatment options. Its lead candidates include lasofoxifene and brelgometon (ATH-1105), and the company conducts clinical trials to evaluate safety and efficacy as part of its mission to improve patient care. LeonaBio is active in medical affairs and patient outreach and has recently presented ATH-1105 at an ALS drug development summit, indicating involvement in neurodegenerative disease research.

📋 Description

• 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 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 clinical and regulatory documents • Provide statistical input and leadership for regulatory submissions and health authority interactions, including 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 • 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 • Contribute to biostatistics standards, processes, and best practices, including applicable CDISC standards and statistical programming conventions • Communicate complex statistical concepts and clinical results clearly to technical and non-technical audiences • Balance strategic leadership with hands-on scientific execution in a lean biotechnology environment • Report to the Chief Medical Officer

🎯 Requirements

• 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 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 • Solid tumor oncology experience 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 the last week of December • 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 • Annual bonus eligibility • Equity eligibility • Full benefits package