Senior Director, Biostatistics

🕒 il y a 20 jours

☕ Washington – Distant

☕ Washington – Remote

💵 $270 000 - $290 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 1%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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LeonaBio

Site WebLinkedInTous les Emplois

51 - 200 employés

🧬 Biotechnologie

💊 Pharmaceutique

🏥 Santé

💰 €103 500 000 Post IPO equity en 2021-02

Biotechnology • Pharmaceuticals • Healthcare

LeonaBio est une entreprise biopharmaceutique en phase clinique, focalisée sur le développement de thérapies innovantes à petites molécules pour les maladies graves avec peu d'options de traitement. Ses principaux candidats comprennent le lasofoxifène et le brelgométon (ATH-1105), et l'entreprise mène des essais cliniques pour évaluer leur sécurité et efficacité dans le cadre de sa mission d'amélioration des soins aux patients. LeonaBio est active dans les affaires médicales et la sensibilisation des patients et a récemment présenté l'ATH-1105 lors d'un sommet sur le développement de médicaments pour la SLA, indiquant une implication dans la recherche sur les maladies neurodégénératives.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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