Principal Statistical Programmer

JOB DUTIES: Write SAS programs that produce or validate tables, listings, figures and analysis datasets, in support of clinical studies or complex integrated analyses for submission. Develop and follow good programming practices, including adequately documenting SAS code. Perform, plan and coordinate project work to ensure timely, quality delivery across multiple projects. Use, modify, and maintain existing SAS code. Write specifications to describe programming needs. Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency. Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. Provide input into, or lead general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations). Assist or lead efforts to develop programming processes consistent with industry best practices. Review DMP, eCRF specs, and other clinical data management documents. Review statistical analysis plans and other related documents. Partner with or oversee CROs or programming vendors to perform any of the above tasks. Hybrid in-office/remote position., documentation for accuracy and compliance; review Statistical Analysis Plans (SAPs) and related clinical study documents to ensure alignment with study objectives and regulatory requirements; develop, validate, and maintain SAS programs to generate Safety and Efficacy tables, listings, figures (TLFs), and analysis datasets for clinical trial reporting; modify, enhance, and maintain existing SAS code to support ongoing clinical programming activities and improve efficiency; prepare technical programming specifications documenting programming requirements, data derivations, and validation procedures; design, develop, validate, and maintain reusable global macros and automated systems to streamline repetitive programming tasks and improve operational efficiency; utilize SAS to analyze and report clinical trial data for regulatory submissions and internal review purposes; review and develop technical programming specifications and SAS programs in accordance with regulatory and industry standards; apply CDISC standards, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), in the preparation and validation of clinical datasets; create eSub package for Clinical trial reporting for FDA submission; apply statistical methodologies and programming techniques to support the analysis, interpretation, and reporting of clinical

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Bachelor’s degree in Engineering (any), Information Technology, Information Systems, Computer Science or related field of study and eight (8) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Provide input into and/or lead standardization initiatives related to case report forms (CRFs), query checks, statistical programming standards, and data presentation formats for Clinical trial reporting; review Data Management Plans (DMPs), electronic Case Report Form (eCRF) specifications, and other clinical data management