- Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
- Generating SDTM domains, ADaM datasets
- Providing programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells;
- Writing SAS programs to generate derived analysis datasets, perform analysis, and TFLs, performing ad hoc flexible and rapid programming arising from questions generated from planned analyses and results;
- Performing programming validation to ensure the quality of analysis datasets and programming outputs; ensuring consistency and adherence to standards within the project;
- Creating Define Files and converting TFLs to the required format for eSubmission,
- Providing programming support for the preparation of integrated reports, submissions and post-submission activities;
- Converting, verifying and integrating multiple sources of incoming data for the creation of analysis datasets; serving as a coordinator when multiple programming resources (e.g. CROs or contractors) are used
- Contributing to the creation, maintenance, and validation of standards for outputs and macros.
- Bachelor’s degree in computer science, statistics, mathematics, life sciences or other relevant degree.
- 7 years of statistical programming experience in the pharmaceutical/biotechnology industry.
- Strong understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models
- In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices.
- Demonstrated proficiency in using SAS to produce derived analysis datasets and produce tables, figures, listings, (TFLs) and graphs (required for adhoc analysis).
- Working knowledge of Pinnacle 21
- Experience working with raw data (Rave) and overall knowledge of Rave database/data structure.
- Experience working on PK data/analysis
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