VP, Clinical Biostatistics

United StatesRemoteFull-timemid

Other

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Requirements Summary

Partner with clinical development, regulatory, medical affairs, and other key stakeholders to drive data-driven decision-making. Collaborate with external partners,

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As a VP, Clinical Biostatistics at Enveda, will provide strategic leadership and operational oversight for the design, analysis, and reporting of clinical trials across all stages of development. This individual will work collaboratively with cross-functional teams to ensure the delivery of high-quality statistical and data management support, driving clinical programs toward successful trial design and execution as well as regulatory submissions and commercialization.

Additionally, this role will be responsible for building and leading a high-performing clinical biostatistics team using internal and external resources. The successful candidate will play a key role in recruiting, hiring, and overseeing biostatisticians, programmers and vendors to support the growth and success of the organization.

The ideal candidate is an experienced biostatistics professional with deep expertise in small molecule drug development, a proven track record of leading teams across multiple therapeutic areas, and the ability to operate in a fast-paced, innovative environment.

As a member of the Clinical Operations team, you will report to our SVP, Clinical Operations.

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 Enveda 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

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, 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.

Excellent leadership, communication, and collaboration skills, with the ability to work effectively across functions and levels.

A strategic thinker with a hands-on approach and a passion for innovation.

We hire for trajectory, not just credentials. If you meet most of the above and care deeply about this problem, we want to hear from you.

We're a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than the industry standard. We recently raised $311M in a Series E, bringing total funding to over $845M, and doubled our valuation to $2B. We now have three oral medicines in the clinic, including our lead drug, ENV-294, in Phase 2 trials for eczema and asthma. Forbes named us one of America's Best Startup Employers, and Newsweek recognized us as a Top 100 Most Loved Workplace. We're still early, and most of the best work is ahead of us.

Benefits (Starting Day 1): Medical, dental, and vision covered at 90%, 401(k) with company match, flexible PTO and a company-wide weeklong recharge break, adoption assistance

Our Process: We move fast and respect your time. Typically: a recruiter screen → hiring manager conversation → work sample, technical interview, & culture interview.

Our Values: Curiosity | Agency | Journey | Charity | Unity

At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. Apply now and join a team committed to shaping the future of drug discovery.