AssocDirector,StatisticalProgramming

## Accountabilities Lead and oversee statistical programming activities for clinical studies, ensuring timely and high-quality deliverables. Develop and/or supervise the creation of analysis datasets, tables, listings, and figures for clinical trial reporting and regulatory submissions. Collaborate with Clinical Development, Biostatistics, and cross-functional teams to align on study deliverables and timelines. Ensure programming outputs and documentation comply with internal standards, regulatory requirements, and industry best practices. Design, review, and validate analysis files and programming specifications for clinical data reporting. Support regulatory submission activities, including integrated analyses, filings, and responses to health authority queries (FDA, PMDA, etc.). Anticipate resource needs and manage workload prioritization across multiple concurrent projects. Drive process improvements and harmonization of statistical programming practices across therapeutic areas. Provide technical leadership and mentorship to programming team members. Resolve complex programming, data, and reporting issues in time-sensitive environments. Requirements: Bachelor’s, Master’s, or PhD in Biostatistics, Computer Science, or a related quantitative field, with relevant pharmaceutical/biotech experience (3–10+ years depending on degree). Extensive experience in statistical programming within pharmaceutical or CRO environments. Strong hands-on expertise with SAS programming, including macros and advanced analytics. Deep understanding of clinical trial design, analysis, and regulatory submission requirements (FDA, PMDA, ICH, GCP). Advanced knowledge of CDISC standards (SDTM, ADaM, CDASH). Proven experience supporting regulatory submissions, integrated analyses, and post-submission activities. Strong ability to manage multiple complex, time-sensitive projects simultaneously. Excellent communication, collaboration, and stakeholder management skills. Strong problem-solving sk