About The Position

The Senior Manager, Statistical Programming provides leadership and oversight for a global team of Statistical Programmers, ensuring high-quality work that meets established timelines, budget expectations, industry standards, and internal processes. The role manages and coordinates statistical programming activities across clinical development projects, including the creation and review of SDTM and ADaM datasets, Tables, Listings, and Figures (TLFs). The position coaches, mentors, and develops team members while fostering continuous learning, collaboration, and excellence. It also contributes to process improvements, standards development, operational efficiency, and quality. The role oversees a portfolio of studies, supports project delivery and financial management, and helps ensure work meets or exceeds client expectations. The Senior Manager partners with internal teams and senior leadership, supports departmental resource forecasting and performance metrics, and represents Statistical Programming in internal and external settings such as audits, bid defenses, and conferences. The role also leads or supports special projects, regulatory submission integration work, hiring strategies, and other initiatives that advance departmental goals.

Requirements

  • Bachelor’s degree or higher in mathematics, statistics, biostatistics, computer science, or a related discipline.
  • 10 or more years of experience in Statistical Programming.
  • Experience with SAS and R.

Nice To Haves

  • Experience in a contract research organization (CRO) is preferred.

Responsibilities

  • Manage a team of Statistical Programmers.
  • Oversee project activities related to quality, budget, timelines, and appropriate resourcing.
  • Provide continual feedback, coaching, and development support to team members; support their growth within the Statistical Programming function.
  • Participate in performance management, including reviews, development, and problem mitigation, and review and assess prospective team members.
  • Develop best practices and contribute to controlled documents and departmental standards.
  • Maintain knowledge of industry expectations and best practices; identify departmental issues and work with senior leadership to resolve them.
  • Oversee a portfolio of studies to ensure Statistical Programming work is completed on time, within budget, and meets or exceeds client expectations.
  • Support Operational Excellence and act as a senior reviewer and support resource for Statistical Programming work.
  • Lead or support creation of client deliverables, particularly for large, complex, or high-priority opportunities.
  • Support the creation of templates, reusable text, and other work products that improve quality or reduce cost and effort.
  • Represent Statistical Programming to internal senior leadership and external organizations on performance, quality, goals, and related topics, including at audits, bid defenses, and conferences.
  • Support the Director, Biostatistics on corporate goals, department development, industry trends, and other relevant topics.
  • Lead special projects or initiatives to improve departmental efficiency, profitability, or operational excellence.
  • Develop clear goals and expectations for the team and aid in developing the Statistical Programming team, including hiring strategies.
  • Manage project financials for studies led by direct reports.
  • Plan and coordinate statistical programming support for integration work for regulatory submissions.
  • Consult with applicable internal teams on statistical programming issues for clinical trials across therapeutic areas.
  • Support the Biostatistics Director or equivalent with department-wide resource forecasts, planning, metrics, and KPIs.
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