AD/Principal, Statistical Programming Consultant

AD/Principal, Statistical Programming Consultant W2 Contract Pay Rate: $100- $125 per hour Location: Redwood City, CA - Remote Role Job Summary: The Associate Director of Statistical Programming will report to the Senior Director of Statistical Programmers and is responsible for leading statistical programming activities for one or more compounds, indications, or a therapeutic area. This role must effectively interface with Statistics, Clinical Science, Medical Writing, Regulatory Publishing, and Development Operations. Duties and Responsibilities: • Lead programming efforts for two or more clinical studies, acting as the primary point of contact for programming deliverables. Review and approve all programming outputs to ensure accuracy and consistency. • Create SAS programs to develop and/or validate SDTM datasets, ADaM datasets, and TFL outputs according to CDISC and internal standards. Ensure full regulatory compliance and maintain traceability. • Maintain accurate ADaM programming specifications and indices of programming deliverables. • Review and approve SDTM mapping specifications, annotated CRFs, and key SDTM domains. • Create documentation for regulatory filings, including reviewers' guides and data definition documents. • Collaborate with external vendors, providing oversight and guidance to ensure high-quality, timely deliverables. • Collaborate with colleagues from all functional areas to ensure high-quality deliverables. Represent the Statistical Programming function in study team meetings. • Drive the development of departmental standards, SOPs, macros, tools, and processes that improve the efficiency of producing analytics across programs. • Adopt a strategic approach to producing analytical deliverables, incorporating innovative tools and methods where needed. • Mentor and provide technical guidance to junior-level statistical programmers. Requirements and Qualifications: • BS or MS preferably in Data Science-related fields (e.g., Statistics, Mathematics, Epidemiology, Health Economics, Computer Science, Bioinformatics, etc.). • Minimum of 8 years of experience in the analysis of clinical trial data. • Minimum of 2 years of demonstrated leadership experience managing projects, vendors, and people. • Must have advanced knowledge in Base SAS, SAS Macro, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS. • Expertise with CDISC standards and regulatory agency data guidelines. • Submission experience highly preferred. Desired Skills and Experience Statistical Programming, Clinical Trial Data Analysis, SAS, Base SAS, SAS Macro, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS, CDISC Standards, SDTM, ADaM, TFL Development, Regulatory Submissions, FDA Compliance, Data Validation, Programming Quality Control, Clinical Data Standards, Annotated CRFs, SDTM Mapping, ADaM Specifications, Data Traceability, Regulatory Documentation, Reviewer Guides, Data Definition Documents, Cross-Functional Collaboration, Vendor Management, Project Leadership, Study Lead Programming, Statistical Analysis, Development Operations, Medical Writing Collaboration, Regulatory Publishing, SOP Development, Macro Development, Process Improvement, Analytics Optimization, Mentorship, Technical Leadership, Pharmaceutical/Biotech Data Programming Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside 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.