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.