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Position: Associate Director, Statistical Programming - Late R&I
Institution: AstraZeneca
Location: Mississauga, Ontario, Canada
Duties: Lead Statistical programming deliverables for regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements; Lead delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations; Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB); Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
Requirements: Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area; Extensive experience in clinical drug development or healthcare; Advanced SAS Programming, CDISC standards knowledge and industry best practices; Excellent interpersonal skills
   
Text: Associate Director, Statistical Programming - Late R&I Lead Statistical programming deliverables for regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements; Lead delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations; Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB); Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area; Extensive experience in clinical drug development or healthcare; Advanced SAS Programming, CDISC standards knowledge and industry best practices; Excellent interpersonal skills
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