You will be working in the Oncology Biometrics Programming department reporting to a Sr. Director, Statistical Programming, providing leadership and management of standards governance activities at the therapeutic and study level related to the planning, execution and delivery of the data and the analysis reporting of clinical development. The scope of work includes, but is not limited to, the governance of clinical data standards change requests, development of new Oncology TA standards, and participation in cross-TA standards development activities
Requirements:
Bachelor’s or Master’s (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field; Support the Oncology Therapeutic Area Standards Definition Team by reviewing change requests from oncology study teams for standard components (with focus on SDTM, ADaM, TLF) to ensure compliance with the AZ & CDISC standards, regulatory guidelines and AZ Clinical data standards SOP, Protocol/SAP; Support study teams with questions related to oncology standards (with focus on SDTM, ADaM, TLF); Participate in and contribute to working groups (including SME’s) during review and optimisation of existing Corporate and Oncology Standards
Text:
Statistical Programming, Therapeutic Area Standards and Automation Leader You will be working in the Oncology Biometrics Programming department reporting to a Sr. Director, Statistical Programming, providing leadership and management of standards governance activities at the therapeutic and study level related to the planning, execution and delivery of the data and the analysis reporting of clinical development. The scope of work includes, but is not limited to, the governance of clinical data standards change requests, development of new Oncology TA standards, and participation in cross-TA standards development activities Bachelor’s or Master’s (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field; Support the Oncology Therapeutic Area Standards Definition Team by reviewing change requests from oncology study teams for standard components (with focus on SDTM, ADaM, TLF) to ensure compliance with the AZ & CDISC standards, regulatory guidelines and AZ Clinical data standards SOP, Protocol/SAP; Support study teams with questions related to oncology standards (with focus on SDTM, ADaM, TLF); Participate in and contribute to working groups (including SME’s) during review and optimisation of existing Corporate and Oncology Standards
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