Vice President of Biostatistics

JOB TITLE : Vice President of Biostatistics

REPORTS TO : Chief Medical Officer

DATE PREPARED : May 31, 2024

JOB SUMMARY :

AVEO Oncology is seeking an accomplished and highly experienced Vice President of Biostatistics to lead our biostatistics team.

The ideal candidate will possess a deep understanding of biostatistics in the context of oncology drug development, extensive experience with regulatory submissions, and a proven track record of leadership in a dynamic, fast-paced environment.

This role is critical for driving the statistical strategy and ensuring the integrity of clinical data throughout the product development lifecycle.

PRINCIPAL DUTIES :

• Leadership and Management :
• Provide strategic direction and leadership to the biostatistics team, ensuring alignment with corporate goals and objectives.
• Selection and Oversight of CRO and vendors
• Mentor and develop biostatistics staff, fostering a culture of innovation, collaboration, and excellence.
• Oversee the recruitment, training, and performance management of biostatistics personnel.
• Statistical Strategy and Planning :
• Develop and implement statistical strategies for clinical development programs, ensuring robust and innovative statistical methodologies are applied.
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to design and execute clinical trials.
• Provide statistical input into clinical development plans, study protocols, and regulatory submissions.
• Provide and support generation of safety data and regulatory safety updates
• Regulatory Submissions and Compliance :
• Lead the statistical component of regulatory submissions, including the preparation of statistical analysis plans, clinical study reports, and responses to regulatory agency queries.
• Ensure compliance with regulatory requirements and guidelines, including FDA, EMA, and ICH guidelines.
• Participate in meetings with regulatory agencies and provide expert statistical guidance.
• Data Analysis and Interpretation :
• Oversee the analysis and interpretation of clinical trial data, ensuring the accuracy, validity, and integrity of statistical outputs.
• Review and approve statistical analysis plans, datasets, tables, listings, and figures.
• Collaborate with clinical and medical teams to ensure the appropriate interpretation and presentation of clinical study results.
• Stakeholder Engagement and Communication :
• Serve as a key point of contact for internal and external stakeholders on biostatistical matters.
• Present statistical findings to executive leadership, clinical teams, and external partners.
• Represent AVEO Oncology at scientific conferences, industry meetings, and regulatory briefings.

REQUIRED QUALIFICATIONS / EXPERIENCE (BASIC QUALIFICATIONS) :

Education :

Ph.D. or equivalent in Biostatistics, Statistics, or a related field.

Experience :

• Minimum of 10 years of experience in biostatistics within the biotechnology or pharmaceutical industry, with a focus on oncology.
• Extensive experience with regulatory submissions and interactions with global regulatory agencies.
• Proven leadership experience, including managing and developing high-performing teams.

Skills :

• Deep expertise in statistical methodologies and their application to clinical trials in oncology.
• Strong knowledge of regulatory requirements and guidelines for clinical development.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work effectively in a cross-functional, collaborative environment.
• Strong problem-solving and analytical skills with a keen attention to detail.

PREFERED QUALIFICATIONS :

• Experience with late-and early phase clinical trials and market authorization applications.
• Demonstrated ability to drive innovation in statistical approaches and trial design.
• Strong publication record in peer-reviewed journals.

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer.

AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies.

AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development.

AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.