Works with medical writing team to decide on appropriate study design and statistical methodology and provide statistical inputs in the preparation of clinical trial protocols
Estimation of sample size and power for clinical studies
Preparation of Randomization of subjects for clinical studies as per the study protocol
Responsible for statistical issues pertaining to the study such as outliers, missing data and data management
Responsible for statistical integrity, adequacy accuracy of data used
Review of statistical analysis for clinical studies as per respective protocols
Review of reported statistical results which include information in the form of graphs, charts and tables
Analyze and interpret statistical data to identify significant differences in relationships among sources of information
Responsible for review of aCRF, CDISC Datasets (SDTM and ADaM domains) and define files
Preparation of standard operating procedures, statistical analysis plans and work instructions for statistical analysis
Provides accurate and timely answers to routine queries from clients pertaining to statistics
Responsible for co-ordinating with the technical team for installation or renewal or validation of softwares pertaining to pharmacokinetics and statistics on timely basis or as and when required
Preparation and Review of Randomization schedules and statistical analysis of IVPT/IVRT studies

Education:

Master s / bachelor s degree computer science or statistics or related field.

Experience Skills:

2-year relevant experience; or equivalent combination of education, training and experience
Experience in SAS programming for multiple phase clinical trials in a pharmaceutical/CRO environment
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Proven experience with Unix, Linux and Windows operating systems
Proficient in written and oral communication

Biostatistician

Job Description