Executive Director, Statistical Programming

Merck•North Wales, PA

5d•$231,900 - $365,000•Hybrid

About The Position

Reporting to the Head of Statistical Programming (SP), the Executive Director leads a team of statistical programmers and analysts supporting foundational analysis and reporting tools, including standard code libraries, platforms, processes, training, and the generation and management of clinical schedules for our company's clinical trial pipeline. As a key member of the Statistical Programming Leadership Team, this role serves as a strategic and influential leader, models effective people management, and establishes the team’s strategic and operational objectives. The Executive Director also fosters productive collaboration with stakeholders across Biostatistics and Research Decision Sciences, Data Management, IT, Quality, Clinical, and Regulatory Affairs.

Requirements

Master’s degree in statistics, computer science or closely related field is preferred.
At least 12 years of experience in statistical programming, statistics, or closely related activity in a pharmaceutical development environment.
At least 5 years of management experience at the Director level.
Deep knowledge of clinical trial operations, statistical analysis and reporting processes, regulatory and industry compliance standards, and the software development lifecycle.
Extensive experience leading or managing statistical programming teams responsible for analysis and reporting deliverables, including recruiting, hiring, performance management, and employee development.
Strong ability to negotiate and collaborate across business domains and cultures, while managing a broad portfolio of work.
Excellent oral and written communication skills, with experience collaborating in a global environment across functions such as statistics, IT, data management, quality, clinical and regulatory affairs.
Strong interpersonal and project management skills, with the ability to prioritize, align stakeholders, and lead across boundaries.
Experience managing complex, cross-functional programs and ensuring strategic alignment, consistency, and compliance.
Experience working with external vendors for resources and software.
Ability to thrive in a dynamic, fast-paced environment, make sound decisions quickly, and navigate ambiguity effectively.
Clinical Trials Operations
Cross-Functional Leadership
Executive Leadership
Pharmaceutical Industry
Program Management
Project Management
Regulatory Compliance
Reporting Processes
Software Development Life Cycle (SDLC)
Statistical Analysis
Statistical Programming
Statistics
Vendor Management

Nice To Haves

Strong track record of setting strategy for efficient analysis and reporting deliverables and tools.
Experience leading teams through technological change, evolving standards, shifting priorities, and complex challenges.
Ability to implement practical programming solutions with urgency and impact in ambiguous situations.
Experience managing other managers.

Responsibilities

Leads the delivery of analysis and reporting tools, processes, platforms, and training for Biostatistics and Research Decision Sciences (BARDS) staff supporting all clinical trial phases and therapeutic areas, with a focus on regulatory compliance, quality, and efficiency. Partners with Statistics and Statistical Programming leaders, aligns work to the company scorecard, and collaborates with stakeholders and functional service partners.
Manages managers and builds high-performing teams by recruiting, hiring, developing, and evaluating staff; implementing talent management strategies; coaching and mentoring employees; and contributing to succession and workforce planning.
Contributes to the broader vision and strategy of the Statistical Programming organization as a member of the leadership team, challenging the status quo, driving innovation, and applying strong business acumen.
Maintains current knowledge of regulatory guidance and submission standards.
Manages team headcount and budget, and collaborates with vendors and partnership management to maintain flexible and cost-effective programming resources.
Leads departmental and strategic initiatives, developing and executing long-term and annual operating objectives for assigned areas within Statistical Programming.
Represents the organization externally by participating in industry initiatives and engaging with statistical programming and regulatory thought leaders, including contributing to, organizing, or chairing sessions at professional meetings.