Bayside Solutions
Associate Director, Statistical Programming
Bayside Solutions, California, Missouri, United States, 65018
Associate Director, Statistical Programming
Salary Range: $185,000 - $205,000 per year
Location: Redwood City, CA - Hybrid 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.
Requirements and Qualifications
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.
Preferred 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 SAS programming, Base SAS, SAS Macro, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS, SDTM, ADaM, TFL generation, CDISC standards, clinical trial data analysis, regulatory compliance, statistical programming leadership, programming oversight, vendor management, project management, data validation, data mapping, annotated CRFs, regulatory submissions, data definition documents, reviewers' guides, documentation development, cross-functional collaboration, departmental standards development, SOP development, macro and tool development, analytical process optimization, strategic analytics, mentoring, technical guidance, clinical study support, Data Science, Statistics, Mathematics, Epidemiology, Health Economics, Computer Science, Bioinformatics
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.
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Location: Redwood City, CA - Hybrid 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.
Requirements and Qualifications
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.
Preferred 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 SAS programming, Base SAS, SAS Macro, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS, SDTM, ADaM, TFL generation, CDISC standards, clinical trial data analysis, regulatory compliance, statistical programming leadership, programming oversight, vendor management, project management, data validation, data mapping, annotated CRFs, regulatory submissions, data definition documents, reviewers' guides, documentation development, cross-functional collaboration, departmental standards development, SOP development, macro and tool development, analytical process optimization, strategic analytics, mentoring, technical guidance, clinical study support, Data Science, Statistics, Mathematics, Epidemiology, Health Economics, Computer Science, Bioinformatics
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.
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