- 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 , 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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Clinical SAS Programmer - Cambridge, United States - Katalyst Healthcares and Life Sciences
