Executive Director, Statistical Programming

Role Summary

Executive Director of Statistical Programming leads the Biometrics Statistical Programming function across all Therapeutic Areas, reporting to the Head of Biometrics. The ideal candidate will bring a proven track record of functional leadership and strategic judgment in deploying innovative tools, including AI-enabled solutions. The role requires designing and managing a scalable, hybrid resourcing model that integrates internal teams with external partners, and excellence in people leadership and organizational development to drive high-quality programming outputs.

Responsibilities

• Lead the Biometrics Statistical Programming function supporting all TAs, providing strategic inputs and technical expertise to enable scalable, efficient, and consistent workflows and strengthen collaboration across all TAs.
• Partner and collaborate with Biostatistics, Clinical Data Management, Clinical Development, Global Patient Safety, and Regulatory Affairs to ensure aligned and timely analytic and reporting deliverables.
• Oversee operational execution of Biometrics Statistical Programming activities through effective management of internal and external resources, ensuring clear accountability and quality oversight.
• Anticipate emerging workload and resource needs; identify capability gaps early; develop staffing plans and allocate internal/external resources according to priorities and development strategies.
• Negotiate project timelines across programs with competing priorities; manage limited resources to deliver high-quality programming outputs on schedule.
• Ensure adherence to SOPs, WRKs, BEDs, departmental standards, validation practices, and regulatory expectations, promoting consistent compliance across all TAs.
• Ensure the scientific and technical integrity of programming deliverables, fostering a culture of accuracy, reproducibility, and data-driven decision making.
• Provide clarity on expectations for Biometrics Statistical Programmers across all TAs, including delegation, decision-making, and communication frameworks. Empower them to exercise sound judgment, adopt best practices, and contribute proactively to planning and execution.

Qualifications

• Excellent verbal and written communication skills; strong negotiation and interpersonal skills.
• Deep knowledge of the drug development process, regulatory expectations, and industry standards for programming, data structures, and reporting.
• Proven ability to supervise people leaders at multiple levels; ability to delegate, coach, and provide feedback and career development opportunities.
• Ability to provide Statistical Programmers with structured frameworks for decision making and guide consistent and high-quality execution.
• Excellent judgment and problem-solving skills in complex situations; ability to prioritize the most important aspects of an issue.
• Ability to lead strategic initiatives within Statistical Programming and implement infrastructure or process improvements that enhance efficiency and quality.
• Ability to integrate planning efforts with cross functional partners to ensure organizational effectiveness; ability to influence decision making.
• Ability to advise senior leadership on programming strategy, functional needs, and technology modernization.

Education

• Bachelor’s degree or higher in Biostatistics, Computer Science, or related field with 16+ years of relevant industry experience in Statistical Programming supporting biopharmaceutical data.
• Extensive experience with SAS and industry standard programming tools; experience in modern analytics platforms, automation, or AI environments preferred.
• Demonstrated experience designing, implementing, and overseeing an offshore or hybrid resourcing model, including effective oversight of global external programming teams.
• Demonstrated leadership in managing large Statistical Programming groups and contributing to NDAs/MAAs or other regulatory filings.