The purpose of this job is to oversee statistical vendor deliverables (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF), perform programmatic review of SDTM datasets generated by vendor, ensure deliverable quality, and expedite the preparation of compound regulatory submission. It will also maintain knowledge of industry standards and regulatory requirements to create and maintain company level SDTM standards.
- By leading internal programming contractor or by self, perform programmatic review of SDTM data deliverables generated by statistical vendor, ensure deliverable quality for the pivotal studies, for submission compounds,
- Responsibilities include: review Case Report Form (CRF) annotation, Study Data Tabulation Model (SDTM) specification, SDTM dataset, and Pinnacle21 report.
- Develop independent programs to review SDTM dataset generated by vendor, ensure SDTM datasets are in compliance with CDISC and submission requirement, review submission data package, which includes define.xml and Study Data Reviewers Guide (SDRG)
- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning,
- Maintain institutional knowledge of CDISCCDASH, SDTM
- Bachelor's degree from an accredited institution in a technical field such as computer science or mathematics; Master's degree in bio/statistics preferred.
- Bachelor's degree with minimum 7 years (or Master's degree with minimum of 5 years) proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming.
- Advanced working knowledge of SAS programming language used in clinical trials programming.
- Advanced working knowledge of CDISC standards including CDASH, and SDTM/ADaM, and extensive experiences of their implementation in clinical trials analysis.
- Experience developing and/or working with company SDTM standards.
- Knowledge in database structures and set-up.