VP, Clinical Biostatistics

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.