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Form of workJob Description
Responsibilities:
- 5 years of Statistical Programming experience in the Pharmaceutical, Biotechnology, and/or Contract Research Industry.
- Bachelor's and/or master's degree in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences.
- High competence in using SAS/Base, SAS/Macro, SAS/STAT, etc.
- Knowledge of SAS/Graph, and SAS/SQL.
- Knowledge and implementation of: CDISC SDTM and ADaM principals; Relational Databases; Good Clinical Practice principals; Good Programming Practice principals; 21CFR Part 11 Standards principals.
- Good knowledge of industry standards including CDISC data structures (SDTM and ADaM).
- Experience in validating Adams and TFLs.
- Strong knowledge on SAS macros and able to work on modifying/existing SAS programs.
- Great interpersonal skills.
- Excellent communication skills (written and verbal).
- Strong attention to detail.
- Highly organized.
- Experience with creating PK datasets and outputs (ADPC and ADPP), generating datasets for PK analysis, etc.
- Experience in CNS.
- Nephrology background.
- Submission experience.
- Experience with leading studies.
- Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio.
- Experience with all clinical phases I, II, III and IV of trails.
