Talentech Consulting LLC is looking for professional Statistical Programmers to work on our client’s clinical research projects.
In this position, the candidate will work closely with project manager and other team member, assist in reviewing statistical analysis plan (SAP), study protocol, CRF, and analysis file specifications to make sure SAS codes are in compliance with the requirements of SAP and study protocol. Provide SAS programming support for the preparation of integrated reports and FDA submission.
Develop and validate complex SAS programs to create tables, figures and listings (TFLs), generate and validate SDTM and ADaM datasets for multiple phase I-V studies, and provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation of CDISC STDM domain outputs, and integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission.
Gather, maintain and analyze large scale of safety data that are collected 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. Be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other agencies, and notify client in a timely matter on any abnormal test results.
Review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of probability principles and statistical methodology; create and modify standard SAS macros for validation, analysis and generation of clinical reports; provide high quality statistical analyses support for the clinical trial studies using statistical theory and SAS/STAT/MACRO/GRAPH/SQL techniques, and participate in preparing clinical study results for FDA submissions using SAS; write intense QC
documentation for every stage of reporting from extraction to the final reporting of the tables.
In addition, work closely with project manager and other team member, and assist in client’s inquiries on clinical trial related statistical analysis with developed statistical techniques/tools.
At least a bachelor’s degree or equivalent in Statistics, Biostatistics, Mathematics, or life science related disciplines, such as Pharmacy, Biochemistry, Chemical Engineering.
The candidate must have extensive knowledge of statistics and its application, strong skills in SAS programming and data analysis for clinical study.