Statistician

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General Responsibilities:

We are looking for a professional Statistician to work on our client’s clinical research projects.   As a Statistician,  general duties include but not limited to: 

  

  • Work closely with project manager and other team members, prepare and review statistical analysis plan (SAP), study protocol, CRF, and analysis file specifications.
  • Gather, maintain, analyze and interpret large scale of safety data that are collected either, during pre-clinical studies conducted in bioresearch labs, or during clinical trials.
  • Use solid SAS/STAT/MACRO/GRAPH/SQL techniques to interpret and report the data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. 
  • Perform statistical analysis using various statistical procedures and prepare final study report of statistical analyses, including information in the form of graphs, listings and tables, processing large amount of data for statistical modeling and graphic analysis using advanced SAS tools.  Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy.
  • Develop and validate complex SAS programs, SAS macros to create tables, listings and graphs (TLGs), generate and validate SDTM and ADaM datasets
  •  Provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation of CDISC STDM domain outputs in accordance with SOPs, SOIs and guidance for multiple phase I- V clinical studies,  and integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission. 
  • Manipulate, analyze and report CDISC data by SAS/STAT including PROC LIFETEST, PHREG, MEANS, SORT, FREQ, SUMMARY, TANSPOSE, COMPARE, NPAR1WAY, ARRAY. Provide statistical input for the preparation of final study reports and other required documents.
  • In addition, work with project manager, assist clients in their inquiries on clinical trial related statistical analysis with developed SAS tools and techniques.

  

Requirements:  at least bachelor or higher degree in Statistics, Industrial Mathematics or close related fields. Master’s degree is highly preferred.  The candidate must be solid knowledge of statistics and statistical computing, strong skills in statistical methods, statistical analysis and SAS programming (using SAS/SQL/Macros/Graph and SAS report generation) for clinical study.