Associate Director of Data Standards & Statistical Programming

5000 Shoreline Ct, Suite 300 South San Francisco, CA 94080 US

Posted: 02/06/2026 2026-02-06 2026-03-09 Employment Type: Contract Job Category: Statistical Programming Job Number: 625516 Is job remote?: Yes Country: United States

Job Description

Position Summary: Associate Director of Data Standards & Statistical Programming

The Associate Director of Data Standards & Statistical Programming will be responsible for Planning and tracking the statistical programming activities including SAS macro development at both the program level and the study level. They will also be responsible for overseeing and managing the workflow of required clinical data listings, summary tables, figures, and Define.xml files on our programs. The DSSP will support the Biostatistics and data management teams with ensuring SOPs and other departmental resources remain up-to-date.

Job Description

What you’ll do:

• Planning and tracking the statistical programming activities including SAS macro development at program level and study level.
• Coordinating tasks across multiple studies within a program collaborating with CRO, Biostatistics and Data management on key deliverables.
• Ensuring the latest CDISC standards are implemented and followed
• Designing, developing and validating computer programs to analyze clinical data. Defining departmental standards and SOPs as needed.
• Overseeing and managing the workflow of required clinical data listings, summary tables, figures and Define.xml files on the program.
• Mentor junior programmers assigned to the project.
• Manage all statistical programming activities at program and study level.
• Oversee the work of programmers to ensure high quality accurate results.
• Act as a liaison between statistical programming, data management, and biostatistics and plan for optimal workflow and outcomes.
• Exercise independent judgment in developing SOPs, Work Instructions and Processes to enable production of high-quality results.
• Perform statistical analysis to enable interpretation of clinical trial results.
• Create SDTM, ADaM, SAS transport files, Define.xml, Pinnacle 21 reports and reviewer guides for electronic submissions worldwide.
• Generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
• Develop Data set specifications and review TLF Shells,
• Review Data Management Plan, Data validation plan, and edit check specifications.

Requirements:

• MS. (in mathematics, statistics, computer science or equivalent) with 12+ year statistical programming experience in Bio-Pharma industry using SAS to analyze clinical trial data in Phase I/II/III clinical trials.
• At least 8 years of experience using CDISC SDTM and ADAM standards and minimum of 4 years in oncology clinical trials, using RECIST to derive key primary and secondary endpoints,
• Experience in developing datasets and outputs for integrated summaries (ISE/ISS) as statistical programming lead on NDA filings
• At least 4 years in fast paced small or medium biotech is required.
• Solid knowledge of SAS programming language, strong SAS programming and statistical background along with proficiency in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Knowledge of R programming and/or python is a plus

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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