Senior Manager Statistical Programming Lead

hace 4 semanas


Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo
Statistical Programming Expert

The purpose of this role is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. This includes developing tools and macros to improve Daiichi Sankyo programming efficiency, building up standards on SDTM / ADaM datasets, and TFLs.

Key Responsibilities:

• Supporting project lead on outsourced projects, acting as statistical programming subject matter expert (SME) to support outsourced programming activities and being responsible for the programming technical decision.

• Performing programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ensuring correct and effective vendor programming implementation, and expediting the preparation of regulatory submissions.

• Making strategic programming decisions and planning, reviewing Case Report Form (CRF) annotation and SDTM dataset, identifying data inconsistencies and supporting data review, reviewing analysis dataset specifications and ensuring correct interpretation of SAP, developing independent programs to validate study level analysis dataset and TLFs generated by vendor, ensuring analysis dataset in compliance with CDISC and submission requirement, reviewing study submission data package and ensuring its quality and integrity.

• Providing hands-on statistical programming support to regulatory submission and helping submission team in quick turnaround in response to regulatory agencies.

• Developing programming submission strategy, performing integrated analysis of efficacy and safety, generating submission data package, creating TLFs to support submission Q&As, performing ad-hoc and exploratory analysis requested by clinical team, and supporting agency response or potential Advisory Committee Meeting.

• Developing DSI programming standard template on datasets and TFLs to improve efficiency and quality

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