Director, Statistical Programming

Director, Statistical ProgrammingDirect Hire Full-Time RolePay Rate: $103 - $115 per hourLocation: Redwood City, CA - Remote RoleJob 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.Other duties as assignedRequirements 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 experienceDesired Skills and ExperienceStatistical Programming, Clinical Trial Data Analysis, Clinical Studies, Biostatistics Collaboration, CDISC Standards, SDTM, ADaM, Summary Tables, Figures, FDA Regulatory Submissions, EMEA Regulatory Submissions, NDA Submissions, BLA Submissions, CRF Review, Annotated Case Report Forms, Database Build, Data Management Collaboration, Programming Validation, SAS Programming, Clinical Data Standards, Project Standards, Programming Specifications, Vendor Oversight, CRO Management, Contractor Management, Team Leadership, Technical Leadership, People Management, Quality Deliverables, Cross-Study Consistency, Timeline Management, Resource Planning, Process Improvement, Pharmaceutical Development, Regulatory Submission SupportBayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.