Executive Director, Statistical Programming

Merck Merck · Pharma · PA

Executive Director of Statistical Programming at Merck, leading a team responsible for foundational analysis and reporting tools for clinical trials. The role involves people management, strategic planning, and ensuring regulatory compliance within the pharmaceutical development environment.

What you'd actually do

  1. 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.
  2. 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.
  3. 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.
  4. Maintains current knowledge of regulatory guidance and submission standards.
  5. Manages team headcount and budget, and collaborates with vendors and partnership management to maintain flexible and cost-effective programming resources.

Skills

Required

  • 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 have

  • 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.

What the JD emphasized

  • regulatory compliance
  • regulatory guidance
  • submission standards