Description
This role will consist of CDISC data programming lead responsibilities for studies within multiple therapeutic areas. The selected candidate will manage the programming activities to generate SAS edit checks and listings for raw data, 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 and QC checks 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 and Programming staff.Job Description:
Works collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
Generates or oversees the production of statistical output for study reports and integrated summaries.
Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project.
Manages a small team of statistical programmers.
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
Is responsible for all statistical programming activities within a therapeutic project or equivalent.
Provides primary and secondary programming support as needed.
Implements strategic initiatives.
Excellent verbal and written communication skills and interpersonal skills are required.
Has a thorough understanding of clinical trials design and reporting process, as well as regulatory Has the ability to resolve study related issues and conflicts within a therapeutic project.
Must be capable of attending study team meetings as the primary statistical programming contact.
Requirements:
- 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
- 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
- 2 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.
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