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 to ensure 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 that enables effective performance in this role. 5+ years of statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferably 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 remotely and comfortable with virtual collaboration tools. Excellent written and verbal communication skills, and ability to explain technical concepts to non‑programmers and cross‑functional stakeholders. Strong interpersonal and teamwork skills, with the ability to work independently and prioritize across multiple projects. High attention to detail and focus on quality, reproducibility, and traceability in all deliverables. Demonstrated ability to follow SOPs, adhere to project timelines, and contribute to continuous improvement of programming processes. Proactive problem‑solver and critical thinker, willing to adapt and thrive in a fast‑paced CRO environment. Capable of managing multiple tasks and priorities in a dynamic environment with shifting timelines and evolving sponsor needs. Independent decision‑making ability on complex programming and data‑related decisions. Anticipate analytical needs, understand downstream impacts of programming decisions, and proactively identify gaps in data and specifications. Comfortable working across functional teams (clinical, data management, biostatistics, medical writing) and shifting quickly between strategic and tactical tasks. Demonstrate flexibility, adaptability, initiative, and the ability to troubleshoot efficiently in a collaborative team setting. Seniority level: Not Applicable | Employment type: Contract | Job function: Information Technology | Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr