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This role will assume CDISC data programming responsibilities for studies within one therapeutic area. The selected candidate will participate in the programming activities to generate regulatory submission ready SDTM data, annotated CRFs, and data definition documents. The selected candidate will also ensure the process is aligned with industry best practice by going through CRF review, SDTM mapping specifications, source programming, CDISC compliance check, and derivation QC etc.. The selected candidate may also manage SDTM data generation processes with vendors, ensuring completeness, correctness, and consistency according to Gilead standards. This role has a high degree of collaboration with Clinical Data Management staff, Clinical and Statistical Programmers. The ideal candidate will posses BS or above degree in Biostatistics/Computer Science or equivalent field. Relevant statistical programming background
Essential Duties and Job Functions:
Works collaboratively with Biostatisticians, Statistical Programmers, to meet project deliverables and timelines for statistical data analysis and reporting. Assesses the quality of analysis data and performs cross-study analyses. Uses internal macros to automate statistical table, figure, and listing production. Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies, creates MS PowerPoint graphs and in-text tables. Works as a secondary programming contact for two Phase 1-3 studies. Excellent verbal and written communication skills and interpersonal skills are required. Must be able to work concurrently on multiple projects and comply with standards. Has sufficient statistical understanding to follow a statistical analysis plan and use analysis data sets to provide programming support for statistical tables, figures, and listings. Must have experience in the statistical analysis of biomedical data using SAS® software or be certified in the following areas of SAS programming: accessing data, creating data structures, managing data, and generating reports.
Knowledge, Experience and Skills:
3+ years of experience and a BS degree in Biostatistics or Computer Science. 1+ years of experience and a MS degree in Biostatistics or Computer Science. PhD degree in Biostatistics/Computer Sciences or equivalent.
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