Manager, Statistical Programming

Role Description

The Manager, Statistical Programming provides leadership and oversight for a global team of Statistical Programmers, ensuring the delivery of high-quality work that meets established timelines, budget expectations, industry standards, and internal processes. This role is accountable for managing and coordinating statistical programming activities across clinical development projects, including the creation and review of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs). In addition, the role is responsible for coaching, mentoring, and developing team members, fostering a culture of continuous learning, collaboration, and excellence.

The Manager also contributes to departmental process improvements, standards development, and strategic initiatives that enhance operational efficiency and quality. Through effective leadership and partnership, this position supports the achievement of company, departmental, and functional objectives while driving successful project outcomes.

Responsibilities

• Manages a team of Statistical Programmers
• Oversees project activity including aspects of quality, budget, and timelines
• Ensures that all work for relevant studies is resourced appropriately
• Provides continual feedback and development support for all team members
• Supports the growth and development of all members of the Statistical Programming function
• Participates in relevant performance management activities including review, development, and problem mitigation
• Participates in the review and assessment of new team members
• Develops best practices to achieve Statistical Programming department goals
• Contributes to the review and development of controlled documents
• Maintains robust knowledge of industry expectations and best practices
• Identifies any potential issues within the department and works with senior leadership to resolve them
• Oversees a portfolio of studies with Statistical Programming activities to ensure all work is completed on time, within budget, and meeting or exceeding client expectations
• Acts as a senior reviewer and support for Statistical Programming work performed
• Leads and/or supports the creation of client deliverables with an emphasis on large, complex, or other high priority opportunities
• Supports the creation of templates, reusable text, or other work products that may support future work by improving quality and/or reducing cost/effort
• Represents Statistical Programming to internal senior leadership and/or to external organizations (e.g., audits, bid defenses, conferences, etc.) regarding topics of performance, quality, goals, and other relevant topics
• Supports the Director, Biostatistics on topics related to corporate goals, department development, industry trends, and other relevant topics
• Leads special projects or initiatives to help improve the efficiency, profitability, or operational excellence of the department
• Aids in the development of the Statistical Programming team including hiring strategies
• Responsible for project financials of studies led by direct reports
• Plans and coordinates the statistical programming in the support of integration work for regulatory submissions
• Interacts with applicable internal teams to provide a high standard of consultation on issues related to the statistical programming of clinical trials in a variety of therapeutic areas
• Supports the Biostatistics Director or equivalent with departmental wide resource forecasts and planning
• Supports the Biostatistics Director or equivalent in maintaining metrics and KPIs

Qualifications

• Bachelor’s degree (or Higher) in mathematics, statistics, biostatistics, computer science, or other related disciplines
• 10+ years’ experience in Statistical Programming (SAS and R), preferably in a CRO

Benefits

• Make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world
• Join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting
• Work in a diverse environment where values unite the team
• Emphasis on quality, integrity, trust, drive, passion, agility, responsiveness, belonging, and collaborative partnerships