Principle Statistical Programmer
Cambridge, MA Posted: 4/17/2019
In this role you will:
- Be responsible for leading and supporting statistical programming activities for assigned clinical studies, submissions and development initiatives.
- Provide a high level of effective collaboration for statistical programming initiatives to facilitate understanding of statistical programming services and work product.
- Program, validate, maintain and document statistical analysis programs for asset development on the basis of the SAP and following the standard operating procedures and working documents.
- Where applicable, develop innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base.
- Ensure that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standard requirements of regulatory agencies.
- Ensure that datasets, tables, figures, listings and statistical outputs are produced in an efficient manner. Develop specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings and associated metadata.
- Support direction, motivation and oversite of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed.
- Support development and rollout of new standards and process with respect to own statistical programming operations team.
- Ensure compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
- Contribute to and manage statistical programming timelines and commitment to timelines for the study and/or project.
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