Principal Statistical Programmer

Key Responsibilities: Provide end-to-end statistical programming support for clinical studies from study setup through submission Lead and perform development and validation of: SDTM datasetsADaM datasets Tables, Listings, and Figures (TLFs)Ensure all deliverables are compliant with CDISC standards and regulatory requirements Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission-ready datasets, and reviewer's guides Serve as a Principal-level programmer, providing technical leadership and guidance to other programmers as needed Contribute to and help maintain programming standards, macros, and validation processes Review and approve programming deliverables to ensure accuracy, consistency, and quality Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams Proactively identify risks and propose efficient, compliant solutions within timelines

Required Qualifications: Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field Extensive experience as a statistical programmer, with demonstrated Principal-level responsibilities Strong hands-on experience with: SDTM and ADaM dataset developmentTLF programming Regulatory submission deliverables Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements Proven ability to manage complex studies independently from start to finish