VP, Clinical Biostatistics
Description
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
Skills
As published by lever · 7 questions · 4 written answers
Basics
Resume/CV, Full name, Pronouns, Email, Phone, Current location, Current company, LinkedIn URL, GitHub URL, Other website
Pick from a list (3)
- (GDPR/CCPA) - Your personal data will be processed for recruiting related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under the GDPR (General Data Protection Regulation) and CCPA (California Consumer Privacy Act) as necessary for the purposes of the legitimate interests pursued by Enveda, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be retained by Enveda as long as we determine necessary to evaluate your application for employment. You have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. optional
- (Transcription) - Candidate experience will always be top priority for Enveda. We would like to offer you the opportunity to have your virtual interviews transcribed. This will allow your interviewer to spend less time notetaking and more time being present and engaged with you. In addition, transcriptions may help to expedite feedback so you will know what is happening with your candidacy sooner. You can opt out at any time which will not affect your candidacy. Opting in enables you to request a copy of the transcription. optional
- Which of the following best describes your experience with regulatory agencies during clinical development?
Written answers (4)
- Describe your experience leading biostatistics and data management strategy for a clinical development pipeline, including how you have contributed to clinical development plans and regulatory submission strategies across therapeutic areas.
- Describe how you would think about building and leading a clinical biostatistics team, including recruiting, hiring, and mentoring biostatisticians and programmers, and incorporating key vendors in an AI-native company with multiple assets spanning dermatology, metabolic/obesity, rheumatology, respiratory, and neurology.
- Explain your first principle(s) thinking/strategic approach as it pertains to the development of statistical analysis plans, clinical trial protocols, and other key documentation while ensuring data integrity and quality across studies.
- Detail a situation where you had to balance strategic oversight of a clinical biostatistics function with hands-on involvement in a specific study or submission, and describe how you managed both.