VP, Clinical Biostatistics and Data Management

Enveda is looking for a VP, Clinical Biostatistics and Data Management to join our team remotely!

The contribution you will make:

The VP, Clinical Biostatistics and Data Management 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 and data management professionals to support the growth and success of the organization.

The ideal candidate is an experienced biostatistics and data management 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 Development team, you will report to our Chief Medical Officer.

• 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 and data management 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, data managers, 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 CROs 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

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
• 10 years of experience in clinical biostatistics and data management, with significant exposure to small molecule drug development.
• Proven track record of leading and building clinical biostatistics and data management teams, preferably in a biotechnology or pharmaceutical setting.
• Expertise 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.
• If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.

• HR Screen (30 minutes)
• Hiring Manager Interview (45 minutes)
• Work Sample Interview (45 minutes)
• Technical Interview (60 minutes)
• People Leader Interview (45 minutes)
• Enveda Culture Interview (30 minutes)

• Culture: Enveda lives for people
• Salary: $375,000 - $400,000
• Equity
• Healthcare: Medical, dental and vision insurance. Company pays 90% of premium for employee and dependents
• 401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation).
• PTO:  Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays and 1 floating holiday.
• Adoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.

Come join us!

Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you.

Employee Promise

Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work.

Enveda's values

Curiosity:  Learn and challenge.       

Agency:  Own and initiate. 

Journey:  Love the process.

Charity:  Take care of each other.

Unity:  We are one Enveda.

We value your uniqueness

One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles.

Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. Unity is a company value because success depends on trusting, working relationships that respect the commonality and differences of people.

At Enveda we are building a place where every person can do the best work of their lifetime.

Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws.

*Please note jobs may be taken down from our website, this does not mean they have been filled. This is to maintain our candidate experience for current applicants. If you are in the interview process and would like to request a copy of the job description, reach out to your recruiting contact.

Salary : $375,000 - $400,000