Statistical Programmer

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

Technical 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