Vice President Clinical Biostatistics
About the job
- A 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.
- A proven track record of leading and building clinical biostatistics teams, preferably in a biotechnology or pharmaceutical setting.
- Expertise or experience across multiple therapeutic areas, with an understanding of the unique challenges and opportunities in each.
- Deep knowledge of regulatory requirements (FDA, EMA, ICH) and experience with regulatory submissions.
- Strong programming skills in SAS, R, or similar statistical software, and familiarity with EDC systems.
- The ability to work effectively across functions and levels.
- A strategic thinker with a hands-on approach and a passion for innovation.
- Develop and implement the 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.
- Build a high-performing clinical biostatistics team by recruiting, hiring, and mentoring top talent.
- Foster a collaborative and growth-oriented culture within the team.
- Provide leadership, training, and career development opportunities for team members.
- Lead and mentor a team of biostatisticians and programmers.
- Oversee the development of statistical analysis plans (SAPs), clinical trial protocols, and other key documentation.
- Ensure data management processes adhere to industry standards and regulatory requirements, ensuring data integrity and quality.
- Partner with clinical development, regulatory, medical affairs, and other key stakeholders to drive data-driven decision-making.
- Collaborate with external partners, including vendors and regulatory authorities, to ensure the successful execution of clinical trials.
- Represent the company in interactions with global regulatory agencies, including the preparation and review of submission documents.
- Provide statistical input for responses to regulatory queries and support advisory committee meetings as needed.
- Stay abreast of industry trends and advancements in biostatistics and data management methodologies.
- Drive the adoption of innovative approaches, technologies, and best practices to enhance efficiency and data-driven insight.
- Experience leading and building clinical biostatistics teams in a biotechnology or pharmaceutical setting.
About the company
Enveda Biosciences uses machine learning, metabolomics, and robotics to explore the largely untapped natural world for drug discovery. Its main asset is a proprietary high-throughput platform that runs many experiments to generate a comprehensive dataset of small molecules, including their chemical structures, biological activity, and how they distribute in organs. This data helps identify potential drug leads quickly and supports partnerships with healthcare and pharmaceutical companies through collaborations and licensing of discoveries. Unlike many rivals, Enveda focuses on expanding knowledge of natural product chemistry beyond the small portion already known, aiming to accelerate the pace of drug discovery by systematically exploring natural chemical space and building a pipeline for its partners.
Company Size
201-500
Company Stage
Series D
Total Funding
$534.8M
Headquarters
Boulder, Colorado
Founded
2019
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Simplify's Take
What believers are saying
- August 18, 2026 ENV-308 positive Phase 1 data expands investor confidence beyond dermatology.
- March 31, 2026 ENV-294 positive Phase 1b results support advancement into Phase 2.
- April 15, 2026 hiring Christopher K. Porter signals Enveda is building clinical execution muscle.
What critics are saying
- All value depends on Phase 1/2 readouts after the September 2025 Series D.
- ENV-294, ENV-308, and ENV-6946 can each fail independently, destroying pipeline momentum.
- Biotech incumbents and well-funded AI drug hunters can copy claims after clinical validation.
What makes Enveda unique
- Enveda’s nature-first platform has delivered three clinical assets by December 2025.
- ENV-294 is a first-in-class oral small molecule for atopic dermatitis and asthma.
- ENV-308 and ENV-6946 extend one discovery engine into metabolic and inflammatory diseases.
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Benefits
- Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation)
- Medical, dental and vision insurance. 100% coverage of employee premiums and 33% coverage of dependents
- Unlimited paid time off
- Flexible work hours and paid parental leave
- Company-wide weeklong break to recharge in addition to 8 observed holidays