Description Statistical Programming Manager, Evidence Generation

The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality.

• By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity

• Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF) Requirements Apache Spark, Database, Data Science, EO/IR systems, HDFS, Algorithm Implementation, Analytics, Apache Hadoop, AWS Technologies, Cluster Analysis Technology Doesn't Change the World, People Do.®

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