About the role
TechData Service Company LLC is looking for a professional Biostatistician. The candidate is allowed to work remotely in the US.
As a Biostatistician, the candidate will independently work on the assigned tasks and the duties include but not limited to the following:
· Collaborate with statistician and other members of clinical study team to provide statistical support for Phase I-IV clinical trials.
· Write and review Statistical Analysis Plans (SAPs), clinical study protocols, statistical summary reports and Case Report Forms (CRFs), integrated summaries of effectiveness and safety, using appropriate statistical methodologies and principles of biostatistics, by following FDA standards for all phases of clinical studies in various therapeutic areas.
· Analyze and interpret safety and efficacy data that are collected during clinical trials. Review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of statistics theory and statistical methodology.
· Use statistical techniques to analyze clinical data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Also be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other agencies. Communicate with project manager and notify clients in a timely manner on any abnormal testing results.
· Coordinate specifications and guidelines to create analysis datasets and summary tables and listings and figures; participate in preparing clinical study results for FDA submissions using SAS; writing intense QC documentation for every stage of reporting from extraction to the final reporting of the tables.
· Produce tables, listings, figures (TLFs) using various statistical models and summarize the findings using statistical literacy such as boxplot, waterfall plot, histogram, line plots and Kaplan-Meier plots, etc;
· Provide guidance to the data management and statistical programming team; provide high quality statistical analyses support for the clinical trial studies using statistical theory and SAS/STAT/MACRO/GRAPH/SQL techniques; and
· Collaborate with Data Management, Clinical staff and SAS programming team and assist in clients' inquiries on clinical trial related statistical analysis and study protocol issues with developing SAS tools/techniques.
Job requirements: A master's degree or equivalent in Biostatistics, Statistics, Public Health, or closely related fields. The candidate must have solid knowledge of biostatistics/statistics and its applications, strong skills and work experience in clinical data analysis, SAS programming, statistical modeling and reviewing clinical study protocols, manipulating, analyzing and interpreting large scale of data, creating and validating analysis datasets, producing and validating reports for clinical trial projects.
