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Statistical Programming Manager
1 month ago
The Manager, Statistical Programmer will be responsible for providing timely support to the study team on all programming matters according to project strategies. This role is focused on supporting the team in implementing and executing programming and project standards to support in production or validation of CDISC SDTM, ADaM datasets, and Tables, Listings, Figures for clinical study reports, ISS, or ISE for assigned projects.
The incumbent should have hands-on skills and experiences in implementing and executing the programming and project standards to support in production or validation of CDISC SDTM, ADaM datasets, and Tables, Listings, Figures for clinical study reports, ISS, or ISE for assigned projects. Independently provide programming supports to statisticians in planned analysis, adhoc analysis, and demonstrate SAS programming proficiency.
This position will be responsible for leading the programming aspect of a project for all programming deliverables from the single study through to regulatory approval. This position requires a comprehensive knowledge of CDISC standards, clinical trial study design, and electronic data submission requirements. Work collaboratively with study team to meet study deliverables and timeline for statistical data analysis and reporting.
Other responsibilities include but not limited to: develop and maintain standard programs, macros, templates, and libraries for use in clinical studies. The position will be based in Palo Alto or may be remote.
Key Responsibilities
- Develop an expertise within a therapeutic area or standard tool for Statistical Programming function.
- Participate study team meeting to represent the Statistical Programming function to support or lead the study, focusing on data integrity, collaboration and on-time deliverables.
- Has good understanding to follow an analysis plan and prepare standard study SDTM, ADaM data specification and provide programming support for all of required deliverables.
- Process clinical data required for statistical analysis. Develop SAS code or macros for preparing, processing and analyzing clinical data.
- Interact with members of project teams, statistician and data management personnel to perform statistical programming activities.
- Provide support in production or validation of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
Requirements
- A bachelor's degree required in statistics, mathematics or equivalent with at least 6 years experience in pharmaceutical or bio-pharmaceutical industry or a master's degree with at least 4 years in statistics or computer science is preferred.
- Demonstrated good verbal, written communication skills and interpersonal skills.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
