AVP, Biostatistics

Job Description

In Biostatistics and Research Decision Sciences (BARDS), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

The Associate Vice President (AVP), Late Development Statistics, BARDS, is responsible and accountable for the end-to-end statistical support for a number our company's late-stage products in Oncology. The AVP will work under the direction of the Late Development Statistics Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.  

The AVP provides leadership and direction through senior-level and first-line managers and statistical staff focused on end to end statistical activities that support Women's Cancer, Genitourinary Cancers and Melanoma in the Oncology therapeutic area. The AVP builds and oversees a statistical team of ~20 employees focused on effective, efficient, and seamless cross-functional collaboration to deliver novel strategic program and study design, analysis strategy, and analysis results with highest quality. This individual is responsible for hiring appropriate, qualified staff, coaching and mentoring, talent management including succession and workforce planning, performance management, and employee development. Additionally, the AVP may provide strategic oversight and sponsorship of departmental initiatives.

The requirements for this role include strong strategic insight and decision-making skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in directing multiple teams to execute on business priorities, demonstrated experience in building and maintaining talented teams, and demonstrated collaboration with senior cross-functional leadership to optimize efficiencies in the clinical development space. Preferred skills include experience in the application of AI, machine learning, and real-world data, as well as demonstrated leadership and sponsorship in large-scale strategic initiatives.

Primary Responsibilities:

• Provides strategic oversight for late-stage development statistical support in Oncology therapeutic area (focusing on Women's Cancer, Genitourinary Cancers, and Melanoma) leveraging advanced statistical techniques and methodologies

• Mentors team statisticians in developing adaptive program-level statistical strategies, ensuring alignment with rapidly evolving field, priorities and portfolio needs

• Maintains continuity of technical knowledge, study design, and analysis strategies across various project teams, fostering collaboration and innovation

• Directly or indirectly manages a team of approximately 20 statisticians, including individual contributors, first-line managers, and senior managers, driving disciplined proactive decision-making and technical excellence

• Represents the statistics department at internal governance meetings, health authority meetings, advisory committee meetings, and statistical conferences, showcasing technical expertise, leadership, and communication skills.

• Serves as the statistical lead in one or more high-profile asset development teams, incorporating novel design and analysis methodologies where appropriate to advance project goals.

• Drives people development and talent management initiatives, fostering a culture of continuous learning and professional growth within the team.

Education:

• M.S. or Ph.D. in Statistics, Biostatistics or related field

Required Experience and Skills:

• Minimum of 15 years of work experience (Ph.D.) or 20 years of work experience (M.S.) in the pharmaceutical industry

• Strong expertise in high-quality strategic statistical decision-making, development of study design and analysis and reporting through all phases of development including regulatory submissions

• Demonstrated history of development and execution of innovative clinical trial designs and exploration of novel analysis methods in Oncology drug development

• Proven ability in building, developing and maintaining high performing teams both as a direct manager and a second line manager (i.e., managers of managers)

• Demonstrated collaboration with senior cross-functional leadership in advancing pipeline priorities

• Strong interpersonal skills and executive presence to successfully engage senior leaders in governance meetings and heal