Head of Biostatistics

The Position

The Head of Biostatistics will play a critical role in shaping the future of Verve’s groundbreaking gene-editing programs for cardiovascular diseases. This individual will be at the forefront of innovation, building and leading a high-impact biostatistics function that drives the success of clinical programs and pipeline initiatives. This is a unique opportunity to blend your technical expertise with strategic leadership, shaping evidence-based decision-making while ensuring alignment with company goals and regulatory standards. You’ll take full ownership of the of the biostatistics function, all while inspiring and energizing teams to tackle bold initiatives, foster a collaborative culture, and navigate dynamic challenges. By championing professional growth and inclusivity, you will guide your teams to deliver transformative solutions that advance groundbreaking cardiovascular gene editing therapies and change the future of patient care.

Job Responsibilities

• Strategic Leadership:
  • Develop and implement biostatistical strategies for clinical trials and research studies, ensuring they align with regulatory requirements and organizational objectives.
  • Provide statistical leadership for the design and analysis of clinical trials, focusing on cardiovascular editing gene therapies.
  • Serve as the biostatistics expert for clinical trial programs, from preclinical through late-stage development and regulatory submission.
• Functional Management:
  • Oversee the design, analysis, and interpretation of clinical trial data, ensuring the use of advanced statistical methodologies, including survival analysis, Bayesian methods, and longitudinal data analysis.
  • Conduct power and sample size calculations, ensuring the statistical rigor of study designs.
  • Review and validate clinical trial data for consistency and clarity, ensuring accuracy throughout the trial lifecycle.
  • Provide clear, actionable insights through statistical reports, presentations, and graphical data representations for clinical teams, senior leadership, and regulatory agencies.
  • Assist in developing study protocols by incorporating statistical methodologies that support clinical objectives, participate in preparing and submitting regulatory filings to ensure statistical sections meet regulatory standards (e.g., FDA, EMA)
  • Provide statistical consulting to researchers and clinical staff to optimize trial design and analysis in alignment with business and regulatory goals.
  • Stay abreast of advancements in clinical research methodologies and biostatistics, adapting strategies to meet evolving industry trends and regulatory requirements.
  • Ensure the highest standards of data accuracy, integrity, and consistency in all clinical trial data analysis.
  • Oversee the review and audit of clinical trial data, ensuring compliance with industry best practices and regulatory requirements.
• Cross-Functional Collaboration:
  • Work closely with cross-functional teams, from clinical research, clinical operations, data management, and regulatory affairs to design and execute innovative clinical studies that drive progress and provide valuable insights.
  • Forge strong partnerships with external collaborators, including CROs, academic institutions, and industry leaders, to accelerate program development and amplify the company’s impact.
  • Develop lasting relationships with both internal and external stakeholders, fostering alignment and creating a collaborative environment that supports mutual success and growth.
  • Make key decisions that influence the organization’s long-term performance and strategic objectives.
• Leadership and Mentorship:
  • Lead the growth and development of a high-performing biostatistics team by aligning talent strategies with the company’s vision, fostering a culture of collaboration, creativity, and excellence. Inspire and empower team members to thrive in a dynamic, fast-paced environment, while mentoring them to take on leadership roles and drive high performance, accountability, and innovation.
  • Champion innovation by empowering teams to think creatively, embrace diverse perspectives, and implement best practices.
  • Demonstrate strong interpersonal skills, effectively managing conflicts, fostering respectful interactions, and promoting a collaborative, inclusive workplace culture.
• Other duties as assigned.

Qualifications

• Education & Experience
  • Advanced degree in biostatistics, statistics, mathematics, or a related field.
  • A minimum of 12 years of experience in biostatistics for clinical development, including extensive experience with Phase 3 clinical trials and New Drug Application (NDA) and/or Biological License Application (BLA) submissions.
• Skills & Abilities
  • Strong expertise in statistical methods for diagnostic and clinical development, including mixed effects regression and time-to-event models, along with proficiency in SAS, R, and clinical data management systems.
  • Proven experience leading biostatistics and data sciences in the biotechnology industry, aligning data strategies with program goals and driving innovation.
  • Expertise in shaping and executing statistical strategies for clinical trials, ensuring data integrity, regulatory compliance, and scientific rigor.
  • Experience preparing regulatory submission documents (statistical analysis plans, clinical study reports) and ensuring compliance with industry standards
  • Expertise in designing clinical trials and refining data collection processes with optimal statistical methodologies.
  • Fluent in CDISC data standards, including SDTM and ADaM
  • Knowledge of FDA, EMA, and ICH regulations and guidelines related to clinical trials, biostatistics and data handling
  • Experience in outsourced vendor management and external partnership governance
  • Experience developing departmental standards and process improvement initiatives
  • Proven ability to lead and develop high-performing teams, align talent strategies with the company's vision, foster innovation, and inspire teams while developing future leaders.
  • Demonstrated ability to develop and implement growth-oriented strategies and initiatives.
  • Advanced strategic thinking skills with a track record of anticipating and responding to industry trends.
  • Excellent interpersonal and communication skills, with the ability to navigate complex organizational dynamics.
  • Experience in talent development and aligning employee career goals with organizational objectives.