VP, Clinical Biostatistics

Amino Collective; Northern (KY); Remoto; USD 375.000 - 400.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

401(k) match

PTO + recharge break

Adoption assistance

Descrizione del lavoro

Enveda, a clinical-stage AI-enabled biotech, is seeking a VP of Clinical Biostatistics to lead strategy, analysis, and reporting of trials across development stages. You will collaborate with cross-functional teams to ensure high-quality statistical support and regulatory submissions, while guiding data management to excellence.

The role requires building and leading a high-performing biostatistics team, recruiting and mentoring statisticians, and engaging with regulatory authorities.

Competenze

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
• 10+ years of clinical biostatistics experience with small molecule development.
• Proven track record building and leading clinical biostatistics teams.
• Regulatory submission experience (FDA/EMA/ICH) preferred.

Mansioni

• Define and execute biostatistics and data management strategy across the development pipeline.
• Lead the biostatistics team, mentor staff, and manage external partners.
• Oversee SAPs, trial protocols, and key regulatory documents.
• Collaborate with cross-functional teams for data-driven decisions.
• Represent the company in regulatory interactions and submissions.
• Drive innovative statistical methodologies and data management best practices.

Conoscenze

SAS programming

R programming

EDC systems familiarity

Formazione

Biostatistics degree (PhD or MSc)

Strumenti

SAS

R

Descrizione del lavoro

Let’s build the future of medicine - together.

VP, Clinical Biostatistics

Remote |Full-time | $375k-$400k

YOUR ROLE

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.

WHAT YOU'LL DO

Strategic Leadership:

• 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.

Team Building and Leadership:

• 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.

Operational Oversight:

• 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.

Cross-Functional Collaboration:

• 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.

Regulatory Engagement:

• 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.

Innovation and Continuous Improvement:

• 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

WHAT WE'RE LOOKING FOR

• 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.

ABOUT ENVEDA

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.