Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ībility to learn new systems and function in an evolving technical environment.Ībility to manage competing priorities and flexibility to change.Ībility to successfully work as part of a global team. Knowledge and understanding of the programming and reporting process. Provide relevant training and mentorship to staff and project teams as appropriate. Maintain and expand local and international regulatory knowledge within the clinical industry.ĭevelop knowledge of SAS and processes/procedures within other Parexel functional areas. Use efficient programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.Īssist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.ĭeliver best value and high quality service.Ĭheck own work in an ongoing way to ensure first-time quality. The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data.
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