Director, Statistical Programming

Location: Redwood City, CA - Hybrid Role Job Summary: The Director of Statistical Programming will have primary responsibility for the planning, execution, and completion of all statistical programming activities. Duties and Responsibilities: Lead and manage statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistencies. Collaborate with Biostatisticians in the creation, implementation, and maintenance of programming for each study, accounting for timelines, resources, and quality deliverables; ensure programming has been carried out per industry and internal standard practice. Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage; review annotated case report forms. Provide technical leadership and guidance to the programming team and vendors around project conventions, standards, best practices, and specifications. Provide support in the production/validation of SDTM, ADaM, summary tables, and figures. Manage oversight of contractors and CROs. Manage statistical programming support of potential FDA/EMEA regulatory submissions, following CDISC standards. Contributes to the departmental process. Requirements and Qualifications: A minimum of 12+ years of experience in statistical programming and analysis of clinical trial data with demonstrated increasing responsibility. Experience programming for and contributing to an NDA or BLA submission preferred. Experience working with CROs. Master's degree or above in statistics, data science/analytics, computer science, or other relevant scientific field. At least 5 years of management experience Desired Skills and Experience Statistical Programming, Clinical Trial Data Analysis, CDISC Standards, SDTM, ADaM, Summary Tables, Figures, Statistical Programming Deliverables, Clinical Study Programming, Regulatory Submissions, FDA Submissions, EMEA Submissions, NDA, BLA, Annotated CRF Review, Database Build Support, Data Management Collaboration, Biostatistics Collaboration, Programming Standards, Programming Specifications, Quality Control, Validation, Cross-Study Consistency, CRO Oversight, Contractor Management, Vendor Management, Technical Leadership, Team Management, Clinical Data Standards, Statistical Programming Process Improvement, Statistics, Data Science, Data Analytics, Computer Science, Clinical Research, Biotechnology, Pharmaceutical Development #J-18808-Ljbffr Bayside Solutions