Senior Statistical Programmer

Bachelor’s degree or equivalent work experience preferred 5+ years 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 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 trials 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

Perform the role of Lead Statistical Programmer for assigned projects Develop specifications for SDTM datasets and ADaM datasets Develop SAS programming to produce SDTM and ADaM datasets Develop specifications and SAS programming for Tables, Listings, and Graphs (TLGs) Create and maintain SAS programs for analysis and reporting of clinical trials Develop analysis datasets for trial level reporting and integrated safety and efficacy activities Program and QC data listings, summaries, and Graphs Develop re-usable utility macros to support programming tables, listing, and graphs Collaborate with the project team to ensure timely and high-quality deliverables Create submission-ready standard data presentations and data sets Maintain all project documentation Mentor statistical programmers Ensure compliance with eClinical Solutions and industry quality standards