Executive Director - Product Development Statistics

Role Summary

Executive Director - Product Development Statistics will provide strategic and statistical leadership to all assets in the product development portfolio and will supervise, develop, and manage the product development statistics team. The role requires strong technical leadership, initiative, and the ability to communicate the value of sound statistical practices to a broad set of scientific partners.

Responsibilities

• People Leadership: Responsible for coaching and mentoring staff for excellence; accountable for overall performance of direct reports; responsible for directing employee career development; provide leadership and direction regarding departmental policies, organizational goals, performance management, and company policies; ensure staff receive appropriate training; responsible for recruiting, hiring, onboarding, and integrating new staff.
• Develop, Implement, and Manage Statistical Leadership: Ensure proactive leadership development at all levels; accountable for developing and retaining top talent and managing performance; provide statistical leadership at strategic and tactical levels; oversee management of product portfolio support including assignment and allocation of Statistics resources; collaborate with Regulatory, Discovery, Development, Manufacturing, Medical, GPS, and other partners; ensure compliance with internal and external standards and SOPs; maintain a work environment aligned with company values.
• Statistical Activities: Conduct experimental design and analysis for chemists/biologists, formulation scientists, analytical chemists; support development of long-term and accelerated stability studies; develop and implement novel methods to advance drug development and manufacturing; author/review CMC regulatory submission sections; collaborate on applied research projects in modeling, experimental design, process control, multivariate analysis, Bayesian methods, and quality by design.
• Communication of Results: Collaborate with team members and external partners to communicate development study results clearly; assist with manuscript or oral presentations; present results in meetings and at scientific meetings.
• Regulatory Compliance: Perform work in compliance with corporate, local, and departmental policies, procedures, processes, and training.

Qualifications

• Minimum Qualification Requirements: Ph.D. in Statistics, Biostatistics, or Industrial Engineering with at least 15 years pharmaceutical experience.
• Additional Skills/Preferences: At least 5 years of management or leadership experience; proven leadership in managing a large portfolio and people; deep knowledge in one or more statistics disciplines (e.g., experimental design, Bayesian methods); deep understanding of applying statistical methods to pharmaceutical product development; strong strategic thinking, problem-solving, attention to detail, and results-oriented behavior; excellent communication, teamwork, and negotiation skills; proficient in R and JMP.

Education

• Ph.D. in Statistics, Biostatistics, or Industrial Engineering (as noted in minimum qualifications)

Skills

• Proficient in R and JMP
• Strong communication, leadership, and collaboration capabilities
• Strategic thinking and ability to influence cross-functional teams

Additional Requirements

• None beyond what is listed in the Qualifications/Skills sections.