VP, Clinical Biostatistics

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $375.000 - $400.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

🦅 Patrocina Visto H1B

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Enveda

201 - 500 funcionários

Fundada em 2019

🏥 Saúde

💼 Consultoria

🏭 Manufatura

💰 $150.000.000 Series D - Enveda Biosciences em 2025-09

Healthcare • Consulting • Manufacturing

A Enveda é uma empresa de biotecnologia que utiliza uma plataforma proprietária para decodificar e traduzir a diversidade química da natureza, acelerando a descoberta de fármacos de pequenas moléculas. Ao purificar, identificar e caracterizar rapidamente moléculas de fontes naturais complexas, a Enveda pretende colocar um vasto espaço químico, derivado evolutivamente, nas mãos dos exploradores de medicamentos para descobrir tratamentos mais rapidamente e expandir o pipeline de terapêuticos.

Descrição

• Provide strategic leadership and operational oversight for the design, analysis, and reporting of clinical trials across all stages of development • Ensure high-quality statistical and data management support for clinical programs • Drive clinical programs toward successful trial design and execution, regulatory submissions, and commercialization • Build and lead a high-performing clinical biostatistics team using internal and external resources • Recruit, hire, mentor, and oversee biostatisticians, programmers, and vendors • Develop and implement biostatistics and data management strategy for the clinical development pipeline • Provide expert guidance on statistical methods, study design, and data analysis • Contribute to clinical development plans and regulatory submission strategies • Oversee statistical analysis plans, clinical trial protocols, and key documentation • Ensure data management processes meet industry standards and regulatory requirements • Partner with clinical development, regulatory, medical affairs, vendors, and regulatory authorities • Represent the company in interactions with global regulatory agencies • Prepare and review submission documents and provide statistical input for regulatory responses • Drive adoption of innovative approaches, technologies, and best practices

🎯 Requisitos

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field • 10+ years of experience in clinical biostatistics, with significant exposure to small molecule drug development • Proven track record of leading and building clinical biostatistics teams, preferably in a biotechnology or pharmaceutical setting • Expertise/experience across multiple therapeutic areas • Deep knowledge of regulatory requirements (FDA, EMA, ICH) and experience with regulatory submissions • Strong programming skills in SAS, R, or similar statistical software • Familiarity with EDC systems • Excellent leadership, communication, and collaboration skills • Ability to work effectively across functions and levels • Strategic thinking, hands-on approach, and passion for innovation

🏖️ Benefícios

• Medical, dental, and vision covered at 90% • 401(k) with company match • Flexible PTO • Company-wide weeklong recharge break • Adoption assistance

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