- A minimum of 6 years of total experience with a at least 4 years of experience in Statistical programming and/or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or Pharmaceutical or Biotechnology company
- Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.
- Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents (e.g. USFDA and EMEA)
- Good understanding of the statistical programming domain and related processes
- Good verbal and written communication skills coupled with good organizational skills
- Strong Analytical and programming Skills using statistical software SAS or equivalent with understanding of development and/or execution of SAS macros
- Knowledge of R will be an added advantage
- Should have worked on generating and validating tables, listings and figures
- Should have worked on Derived datasets/Analysis Datasets/ADaM/SDTM
- More complex review (programs with high risk)
- Programming and review of outputs for DSUR, PSUR, publications
- Exposure on Exploratory analyses is an added advantage
- Programming and review of analysis data sets.
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