JOB TITLE: Vice President of Biostatistics

LOCATION: Boston MA

JOB SUMMARY:
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:

1. Leadership and Management:

• Selection and Oversight of CRO and vendors
• Provide strategic direction and leadership to the biostatistics team, ensuring alignment with corporate goals and objectives.
• Mentor and develop biostatistics staff, fostering a culture of innovation, collaboration, and excellence.
• Oversee the recruitment, training, and performance management of biostatistics personnel.

1. 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.

1. 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.

1. 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.

1. 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 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.