Experience
2 - 7 yrs
Job Location
Hyderabad, India
Vacancy
1
Designation
Biostatistician
Job Type
ONSITE
Job Description
- 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
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