Job-ID31566396Reference25-04557 Responsibilities: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications. Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned. Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items. Follow departmental SOPs and processes for operational excellence. Lead statistical programming activities for regulatory submissions following CDISC standards. Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan. Take ownership for the completion of SDTM and ADAM specifications for assigned studies. Requirements: Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation Thorough knowledge of SDTM/ADaM specifications and programming Strong SAS programming and graphic programming skills Able to guide the successful completion of major programs and projects. Strong analytical and communication skills Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies. Broad knowledge of medical/biological terminology in relevant therapeutic areas. Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings. Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses. Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus. Experience in management of CROs with respect to statistical programming.
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