Responsibilities
* Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
* Creation of ADaM datasets based on current ADaM standards.
* Creation of Tables, Listings and Figures following J&J specifications
* Creation of Subject Narratives following J&J templates to support Narrative development.
* Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
* QC of all programmed output
* Creation and/or maintenance of detailed specification documentation
* Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
* Includes support for standalone studies as well as integration of data across studies.
* Specific for CDSA - Analysis Standards focus area:
* The service holder is responsible to design, develop and maintain SAS code that is generic and that covers many trial types, can run on many study designs and meet study specific situations based on high reliable study metadata specifying the design and study specific situations.
* The service holder defines and maintains standard clinical data analysis metadata for use in clinical trials, including the traceability from Analysis Datasets and Analysis Results (ADaM) to Study Data Tabulation Datasets (SDTM).
* The service holder pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data. The service holder documents and correctly manages the lineage between master standards and the many pre-configured standards.
* Minimum 8+ years of experience, demonstrating increasing responsibilities.
* At least 2+ years of trial lead experience preferably as the lead for a team of programmers OR At least 2+ years of experience developing SAS/R solutions that are implemented broadly across clinical programs or a therapeutic area.
* Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
* Ability to communicate with cross-functional teams and gather feedback for study specifications and/or data issues. Experience reviewing and writing data specifications.
* High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data
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