Job Details

Senior Manager / Associate Director / Director, Statistics And Statistical Programming

The Senior Manager / Associate Director / Director, Statistics And Statistical Programming, will be responsible for various analysis, programming and validation activities to support clinical trials from early-stage through regulatory submission. They will work closely with Biostatistics, Clinical Data Management, Clinical Operations, and external CRO partners to ensure high-quality, compliant deliverables that support study reporting and regulatory submissions. This will be a hybrid programmer / statistician position, with ability to specialize in either as the department grows.

Job Location: This role can be hybrid out of the San Diego office or fully remote; preference for a candidate based on the West Coast of the United States with some travel to the San Diego office.

Responsibilities include:

• Serve as the lead statistical programmer for clinical studies, providing technical leadership and project management oversight for all programming activities
• Oversee vendors that develop, validate, and maintain SAS programs and associated documentation to generate high-quality regulatory-compliant deliverables, including SDTM and ADaM datasets, define.xml files, reviewer's guides, tables, listings, and figures (TLFs)
• Collaborate with biostatisticians and cross-functional study teams to develop and ensure implementation of Statistical Analysis Plans (SAPs) and programming specifications
• Oversee the creation, review, and maintenance of programming plans, dataset specifications, TLF specifications, review guides, validation documentation, and other required study documentation
• Provide expert-level support and oversight for CDISC implementation, including SDTM and ADaM standards, ensuring compliance with regulatory requirements and industry best practices
• Oversee conformance checks using Pinnacle 21 and other validation tools; identify, troubleshoot, and resolve data and submission issues to ensure submission-ready deliverables
• Generate ad hoc analyses and reports to support Clinical Development, Medical Affairs, Drug Safety, and other functional areas
• Support interim analyses, database locks, clinical study reports, publications, and global regulatory submissions
• Actively participate in development of exploratory analyses, including defining questions of interest and suggesting solutions
• Oversee and manage CRO programming activities, including review, quality control, and acceptance of outsourced deliverables; provide guidance and solutions for programming-related issues
• Contribute to the development, implementation, and continuous improvement of departmental standards, SOPs, work instructions, and programming best practices
• Ensure all statistical programming deliverables comply with company standards, regulatory requirements, and applicable industry guidelines
• Collaborate effectively with internal teams, external vendors, and regulatory partners while communicating project status, risks, and solutions
• Maintain complete and accurate programming records and documentation in accordance with company procedures and submission requirements
• Perform other statistical programming and biometrics-related duties as assigned