Lead Statistical Programmer (Hea Job/ 231)

Mandatory Skills – Statistical Programming – end to end

Human clinical trials  experience

ADAM & TLF

Late face studied – Face 3 & 4

Professional Skills ➢ Experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred. ➢ Strong experience in preparations for NDA filings ➢ Strong knowledge of ICH/GCP 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

Technical Skills ➢ 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