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We are seeking a Senior Statistical Analyst with strong expertise in SAS and R programming, CDISC standards, and clinical trial data analysis. The ideal candidate will collaborate with statisticians and cross-functional teams to develop ADaM datasets, generate TLFs, support regulatory submissions, and ensure high-quality statistical programming deliverables for clinical studies. Primary Responsibilities *Collaborate with statisticians to develop and implement Statistical Programming Plans (SPPs) and Statistical Analysis Plans (SAPs). *Program, validate, and maintain ADaM datasets, statistical analyses, and programming deliverables using SAS and R. *Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports, safety reports, and regulatory submissions. *Create and maintain programming documentation, including specifications, annotated code, validation plans, and programming guidelines. *Perform quality control and validation of statistical programming outputs to ensure compliance with CDISC standards and regulatory requirements. *Support ad hoc statistical analyses, exploratory data analyses, and data visualization requests. *Develop and maintain reusable programming macros, utilities, and automation tools to improve efficiency and consistency. *Provide programming support during regulatory submissions, audits, and inspections. *Collaborate with study teams to resolve programming and data-related issues while ensuring timely project delivery. *Identify project risks, escalate issues when necessary, and provide regular status updates. *Mentor and train junior programmers and contribute to continuous process improvement initiatives. *Stay current with industry best practices, regulatory guidelines, and advancements in statistical programming. Required Skills & Qualifications *Strong proficiency in SAS and R programming for clinical trial data analysis. *Experience programming and validating ADaM datasets, TLFs, and statistical analyses. *Advanced knowledge of CDISC standards, including ADaM and SDTM. *Solid understanding of clinical trial processes, statistical methodologies, and regulatory requirements. *Experience in therapeutic areas such as Oncology, Immunology, Neuroscience, or other clinical domains. *Strong analytical, troubleshooting, and problem-solving skills. *Excellent attention to detail with a strong focus on quality and compliance. *Effective written and verbal communication skills. *Ability to collaborate with statisticians, clinical study teams, and external stakeholders. *Proven ability to manage multiple priorities and meet project deadlines in a fast-paced environment. Preferred Qualifications *Experience supporting global clinical trials and regulatory submissions. *Knowledge of clinical data visualization and exploratory data analysis. *Experience developing standardized SAS macros and programming utilities. *Prior experience mentoring or leading statistical programming teams. *Familiarity with FDA, EMA, and ICH regulatory guidelines for clinical data submissions.