Sr. Statistical Programmer

Responsibilities: • Lead the development, validation, and documentation of CDISC-compliant SDTM and Adam datasets for CNS clinical trials, 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 client deliverables. • Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis-ready datasets and outputs. • Act 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. • Develop 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 impact timelines or analysis accuracy. • Mentor and support junior programmers, fostering quality, consistency, and CDISC best practices across projects. • 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 related scientific discipline; or a combination of education, training and experience to effectively perform the job functions. • 5+ years of statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferably with prior experience in CNS trials. • Experience leading programming efforts for clinical trials, including dataset development, TLF production, and QC oversight. • Advanced proficiency in SAS, 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 Pinnacle 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 able to explain technical concepts to non-programmers and cross-functional stakeholders. • Strong interpersonal and teamwork skills, with a collaborative mindset and the ability to work independently and prioritize across multiple projects. • High attention to detail, with a focus on quality, reproducibility, and traceability in all deliverables (analysis datasets and output). • Demonstrated ability to follow standard operating procedures (SOPs), adhere to project timelines, and contribute to continuous improvement of programming processes. • Proactive problem-solver and critical thinker with a willingness to adapt and thrive in a growing, fast-paced CRO environment. • Able to manage multi-tasks and priorities in a fast-paced, dynamic environment with shifting timelines and evolving sponsor needs. • Able to make complex programming and data-related decisions independently. • Able to anticipate analytical needs, understand downstream impacts of programming decisions, 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 — able to pivot between tasks, troubleshoot issues efficiently, and take initiative in a small, collaborative team setting. Apply tot his job