Associate Director, Statistical Programming

Primary Responsibilities Include

• Lead and oversee statistical programming activities across multiple clinical trials and studies, ensuring high-quality deliverables, operational consistency, and adherence to timelines
• Collaborate with biostatisticians, data managers, clinical operations, vendors, and other cross-functional stakeholders to define programming strategies, priorities, and study requirements
• Develop, validate, review, and maintain analysis datasets (CDISC standards), tables, listings, and figures (TLFs) in accordance with regulatory guidelines, internal standards, and submission requirements
• Provide technical leadership and oversight for statistical programming deliverables across studies, including consistency of implementation and standards application
• Review statistical analysis plans (SAPs) and provide strategic and operational input to support execution feasibility, cross-study consistency, and regulatory readiness
• Perform complex statistical analyses and simulations using SAS and/or R and support advanced analytical and data visualization solutions for clinical trial interpretation and decision-making
• Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD), and oversee submission readiness activities across studies
• Cook up and oversee vendor/FSP statistical programming activities across studies to ensure quality, compliance, and timely delivery
• Build, maintain, and promote reusable, software-agnostic tools, macros, and automation solutions to improve efficiency, scalability, and standardization
• Contribute to the evolution and implementation of departmental programming standards, processes, validation practices, and innovation initiatives
• Mentor and provide technical guidance to junior programmers and may supervise or lead small programming teams or contractors
• Support resource planning, prioritization, and coordination of programming deliverables across studies and programs
• Stay current with industry trends, best practices, regulatory expectations, and emerging technologies in statistical programming and data analysis

Education, Experience, and Skills Requirements

• Bachelor’s degree required; advanced degree preferred in statistics, biostatistics, computer science, life sciences, or a related field
• Minimum of 10 years of statistical programming experience within the pharmaceutical, biotechnology, including multi-study experience
• Advanced proficiency in SAS required; experience with R, Python preferred.
• Strong knowledge and applied experience with CDISC standards (SDTM, ADaM), regulatory submission requirements, and data standards
• Demonstrated experience supporting or leading regulatory submissions, including eCTD deliverables
• Experience coordinating vendor/FSP statistical programming activities across multiple studies preferred
• Demonstrated leadership and project management skills, including the ability to lead cross-functional initiatives and manage multiple priorities simultaneously
• Strong understanding of the clinical development process and cross-functional collaboration with Biostatistics, Data Management and Clinical Development organizations
• Excellent communication, interpersonal, and stakeholder management skills
• Detail-oriented with strong commitment to quality, compliance, consistency, and operational excellence
• Ability to adapt to changing priorities and contribute to departmental strategy, innovation, and continuous improvement initiatives