Associate Director, Statistical Programming

Associate Director, Statistical Programming

Direct Hire Full-Time Role

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.

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.

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