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Job Responsibilities
- Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies
- Participate in the review of statistical analysis plans and TLF specifications.
- Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications.
- Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and other study data related documents.
- Support in the preparation of study reports, regulatory submissions, and annual safety update reports.
- Perform additional analysis and validation for data checking, publication, presentation, poster and ad hoc analysis.
- Work with CRO statistical programmers and perform statistical programming vendor oversight.
Job Requirements
- Skilled programming with SAS programs and macros At least 6 years of experience working on CDISC standards (including SDTM and ADaM models), Tables, Listings and Figures.
- In-depth knowledge of clinical statistics and drug development process.
- Solid verbal and written communication skills.
