VP, Clinical Biostatistics

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $375k - $400k / year

⏰ Full Time

🔴 Lead

👔 Vice President

🦅 H1B Visa Sponsor

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Enveda

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $150M Series D - Enveda Biosciences on 2025-09

Healthcare • Consulting • Manufacturing

Enveda is a biotechnology company that leverages a proprietary platform to decode and translate nature’s chemical diversity for accelerated small-molecule drug discovery. By rapidly purifying, identifying, and characterizing molecules from complex natural sources, Enveda aims to put vast, evolutionarily derived chemical space into the hands of drug hunters to discover medicines faster and expand the pipeline of therapeutics.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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