Senior Statistical Programmer - Katalyst Healthcares & Life Sciences
Durham, NC 27701
About the Job
Responsibilities:
- Collaborate with peers and statisticians to ensure the quality and accuracy thus submission readiness of clinical data by authorities (i.e. SDTM, Adam, tables, figures, listings, and define.xml).
- Lead requested efforts for pooled and exploratory analyses working with clinical programming team and their collection of legacy data.
- Lead the in-house specification and delivery of ISS and Client datasets and associated output (tables, figures, and listings) when not provided by CRO.
- Lead the design and implementation of complex SAS programs for applications designed to report complex clinical trial data in CDISC Adam format.
- Perform additional statistical analyses including support responses to regulatory agencies, create integrated summary of safety and efficacy, support publications and presentations, support reporting of clinical trials with exploratory analyses of available data, replicate CRO and CSL statistician analyses for QC.
- Bachelor's degree Computer Science, Mathematics, Statistics.
- At least 5 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
- Understanding of clinical programming and statistical programming processes and standards.
- Experiences with statistical programming using the SAS software including development and use of SAS Macros.
- Knowledge in CDISC standards (CDASH, SDTM, Adam).
Source : Katalyst Healthcares & Life Sciences
