Job Description

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.

• 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
• ble 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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