Professional Skills & Experience
• Minimum 6 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role
• Strong experience in preparations for NDA filings • Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
• Knowledge of CDISC® related data models like SDTM, and ADAM.
• Experience of working on multiple clinical protocols at the same time.
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
• Excellent team player
T echnical Skills & Experience
• Experience of extracting, manipulating, merging, summarizing, analyzing, and presenting data using SAS procedures
• Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must.
• Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate
• Strong experience in SAS programming in various phases of clinical trial.
• Experience in pooled data analysis and programming.
• Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values.
• Experience in working with relational databases and performance tuning of SAS programming.
• Experience with writing batch scripts and/or shell scripts is a plus
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