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Salary: USD 375,000 - 400,000 / annual
Enveda is seeking a VP of Clinical Biostatistics to provide strategic leadership and operational oversight for the design, analysis, and reporting of clinical trials across all stages of development. This role combines hands-on statistical expertise with team leadership responsibilities.
You will work collaboratively with cross-functional teams including clinical development, regulatory, and medical affairs to ensure high-quality statistical and data management support, driving clinical programs toward successful trial design, execution, regulatory submissions, and commercialization.
Key responsibilities include:
**Strategic Leadership:** Develop and implement biostatistics and data management strategy to support the clinical development pipeline. Provide expert guidance on statistical methods, study design, and data analysis for clinical programs. Contribute to clinical development plans and regulatory submission strategies across therapeutic areas.
**Team Building and Leadership:** Build and lead a high-performing clinical biostatistics team by recruiting, hiring, and mentoring top talent. Foster a collaborative, growth-oriented culture. Provide leadership, training, and career development opportunities. Lead and mentor biostatisticians and programmers. Oversee development of statistical analysis plans (SAPs), clinical trial protocols, and key documentation.
**Operational Oversight:** Ensure data management processes adhere to industry standards and regulatory requirements, maintaining data integrity and quality.
**Cross-Functional Collaboration:** Partner with clinical development, regulatory, medical affairs, and other stakeholders to drive data-driven decision-making. Collaborate with external partners, vendors, and regulatory authorities to ensure successful clinical trial execution.
**Regulatory Engagement:** Represent the company in interactions with global regulatory agencies (FDA, EMA, ICH). Prepare and review submission documents. Provide statistical input for regulatory query responses and support advisory committee meetings.
**Innovation:** Stay current with industry trends and advancements in biostatistics and data management. Drive adoption of innovative approaches, technologies, and best practices to enhance efficiency and insight.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature. The company recently raised $311M in Series E funding (total $845M+), doubled valuation to $2B, and has three oral medicines in the clinic, including ENV-294 in Phase 2 trials for eczema and asthma.
**Requirements:**
- Ph.D. or Master's degree in Biostatistics, Statistics, or 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 in biotech or pharma
- Expertise 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
- Strategic thinker with hands-on approach and passion for innovation
The company values trajectory and welcomes candidates who meet most criteria and care deeply about the mission.
