Senior Manager, Statistical Programmer

Role Summary

Senior Manager, Statistical Programming located remotely, is responsible for providing technical expertise and oversight of programming by CRO partners for analysis and reporting of clinical study data, and hands-on generation of analysis results for rapid responses, ad hoc analyses, and biomarker exploration. This role includes designing and developing SAS programs to produce trial reporting deliverables and ensuring quality control and documentation in alignment with regulatory standards.

Responsibilities

• Aggressively seek out needed specification details for the deliverables.
• Perform quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets and specifications.
• Ensure the quality of tables, figures, and listings (TFLs) on time for electronic submission to regulatory agencies.
• Develop SAS validation procedures and test plans, as necessary.

Qualifications

• Minimum 5 to 10 years of industry experience (pharmaceuticals, biotechnology, or CRO) in developing or overseeing efficient development of submission ready programming code for clinical trials using the SAS-based Statistical Computing Environment.
• Strong CRO oversight experience
• Solid verbal and written communication skills.
• Demonstrated ability to speak up appropriately and ask necessary questions.
• Experienced hands-on skill in programming with SAS is required. Knowledge of additional programming languages is a plus.
• Good knowledge of statistics and oncology drug development process.
• Strong experience performing quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets, associated metadata, and specifications.