Principal / Associate Director, Statistical Programming

Responsibilities

• Lead and contribute to statistical programming activities across multiple clinical studies and development programs.
• Develop, validate, review, and maintain SAS programs used for data access, transformation, analysis, reporting, and regulatory submission activities.
• Review CRO deliverables including SDTM, ADaM, tables, listings, and figures (TLFs), Define.xml packages, and submission deliverables to ensure quality, accuracy, and adherence to company standards.
• Collaborate cross-functionally with Biostatistics, Clinical Data Management, Regulatory Operations, Medical Writing, Medical Affairs, and Clinical teams to ensure consistent and accurate use of clinical trial data.
• Support regulatory submissions including NDA/BLA activities, pooled analyses, integrated summaries of safety and efficacy (ISS/ISE), and responses to regulatory agencies.
• Support the development, implementation, and maintenance of programming standards, macros, automation tools, QC procedures, SOPs, working instructions, and submission processes.
• Participate in process improvement and automation initiatives to improve programming efficiency, quality, and scalability, including evaluation of AI-enabled solutions.
• Collaborate with CRO partners to ensure deliverables are completed according to timelines, quality standards, and regulatory requirements.

Qualifications

• Bachelor’s degree in Mathematics, Computer Science, Data Science, Statistics, or related life science field (Master’s degree preferred).
• 10+ years of total relevant experience in the pharmaceutical/biotech industry with prior regulatory submission experience.
• Strong SAS programming experience including SAS Macro development; knowledge of R programming is a plus.
• In-depth knowledge of CDISC data standards including SDTM and ADaM models, with extensive implementation experience in clinical trials.
• Advanced understanding of statistical concepts supporting clinical data analyses.
• Prior experience overseeing programming activities delivered by CRO partners.
• Experience supporting NDA/BLA submissions, Define.xml, and submission validation processes preferred.
• Strong communication, organizational, problem-solving, and collaboration skills in a cross-functional environment.