Senior Director Biostatistics

Role Summary

Senior Director Biostatistics lead the Biostatistics function within therapeutic areas of the company, providing statistical input to development strategies and implementation plans to support product development or market access objectives in a global organization. Provides expertise and guidance in collaboration with cross-functional groups to establish study design, analyses and strategy, and institutes best practices for planning, execution, interpretation and regulatory submission of clinical projects and studies. Manages resources, sets priorities, and ensures high-quality, timely deliverables; oversees statisticians and ensures adherence to standards.

Responsibilities

• Direct and guide statisticians to ensure high quality and timely deliverables
• Manage a functional or project budget and allocate resources across multiple compounds/indications within therapeutic areas
• Ensure compliance with processes and SOPs, and adherence to global and project standards
• Maintain consistency of standards across therapeutic areas and projects
• Contribute to Clinical Development Plans, submissions, and post-submission strategies
• Represent the company in interfaces with regulatory agencies globally
• Drive strategy for process improvement; contribute to departmental SOPs; provide training on statistical topics
• Participate in industry discussions and represent the company in professional societies
• Encourage innovation and continuous improvement across GBDS
• Identify and address potential issues; oversee resolution for the team
• Engage as a matrix team member on high-level development teams; act as scientific and strategic partner
• Establish new collaborations across functions and maintain stakeholder relationships
• Contribute to functional goal setting and forward planning
• Communicate GBDS Mission and Vision to generate pride and commitment
• Foster inclusiveness, respect for diversity, process compliance, and constructive questioning

Qualifications

• PhD or MS with 12+ years of experience in statistics/biostatistics related to clinical trials, drug development, pharmaceutical industry or healthcare
• Proficiency in SAS, R, or Python; experience with advanced statistical analysis, data manipulation, graphing and simulation
• Excellent interpersonal, communication, writing and organizational skills
• Expertise in applying general and cutting-edge statistical/clinical trial methodologies; ability to align with regulatory agencies and industry standards
• Extensive experience preparing for and participating in global regulatory agency interactions
• Strong collaboration, leadership, and interpersonal abilities
• Experience developing resourcing strategies and recruiting practices; ability to define positions and organizational structures for future needs
• At least 5 years of management experience (direct or matrix) preferred for people manager roles

Skills

• Statistical thinking and statistical programming
• Regulatory knowledge and experience with global interactions
• Leadership and people management
• Cross-functional collaboration and stakeholder management
• Strategic planning and process improvement

Education

• PhD or MS in statistics, biostatistics or related field

Additional Requirements

• On-site/occupancy requirements may vary by role and location; ability to travel as needed for field-based or collaboration activities