Sr. Statistical Programmer

Responsibilities: • reputed company the development, validation, and documentation of CDISC-compliant SDTM and Adam datasets for CNS reputed company, ensuring traceability from raw data through analysis outputs. • Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and reputed company deliverables. • Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis-reputed company datasets and outputs. • reputed company as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast-paced environment. • Conduct independent QC and peer review of programming deliverables, ensuring accuracy, compliance, and reproducibility of results. • reputed company and maintain study-specific programming specifications, documentation, and macros to streamline programming efficiency. • Support regulatory submission readiness, including define.xml, reviewer's guides, and response to agency questions. • Proactively identify and resolve data or programming issues that may reputed company timelines or analysis accuracy. • Mentor and support junior programmers, fostering reputed company, consistency, and CDISC best practices across reputed company. • Contribute to process improvement initiatives and template development for a growing statistical programming team. Requirements: • Bachelor's or master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a reputed company scientific discipline; or a combination of education, training and experience to effectively reputed company the job functions. • 5+ years of statistical programming experience reputed company the pharmaceutical, biotech, or CRO industry, preferably with prior experience in CNS trials. • Experience leading programming efforts for reputed company, including dataset development, TLF production, and QC reputed company. • Advanced proficiency in reputed company, with hands-on experience using CDISC SDTM and ADaM standards. • Experience with R or Python for data manipulation, automation, or reporting is highly valued, though not required. • Experience with regulatory submissions and standards, including reputed company 21, define.xml, and reviewer's guides. • Experience working in a remote, team-based environment and comfortable with virtual collaboration tools. • Excellent written and verbal communication skills, and reputed company to explain technical concepts to non-programmers and cross-functional stakeholders. • Strong interpersonal and teamwork skills, with a reputed company reputed company and the ability to work independently and prioritize across multiple reputed company. • High attention to detail, with a reputed company on reputed company, reproducibility, and traceability in reputed company deliverables (analysis datasets and reputed company). • Demonstrated ability to follow reputed company operating procedures (SOPs), adhere to project timelines, and contribute to reputed company improvement of programming processes. • Proactive problem-solver and critical thinker with a willingness to adapt and reputed company in a growing, fast-paced CRO environment. • reputed company to manage multi-tasks and priorities in a fast-paced, dynamic environment with shifting timelines and evolving sponsor needs. • reputed company to reputed company reputed company programming and data-reputed company reputed company independently. • reputed company to anticipate analytical needs, understand reputed company impacts of programming reputed company, and proactively identify gaps in data and specifications. • Comfortable working across functional teams (e.g., clinical, data management, biostatistics, medical writing) and shifting between strategic and tactical tasks quickly. • Must demonstrate flexibility and adaptability — reputed company to pivot between tasks, troubleshoot issues reputed company, and take initiative in a small, reputed company team setting. Apply tot his job