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Director, Statistical Programming
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Full-time
- Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.
- Manages contract statistical programming staff to ensure proper resource allocation for achieving successful project deliverables.
- Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE).
- Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals.
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