Responsible for the statistical analysis from clinical study data and the application of statistical methods to support clinical trials and data management, including statistical analysis, design, and reporting and involve in the development of standard SAS Macros and programs in accordance with standard programming practices to design and develop Tables, Listings and Graphs as outlined in the Clinical Study Protocol and/ or Statistical Analysis Plan.
Perform the statistical analyses according to study protocol/SAP
Provide statistical support, including methods and interpretation of the statistical results
Generate randomization scheme for clinical studies
Review CRFs, study protocol, and clinical study report (CSR)
Prepare statistical analysis plan
Implement quality control (QC) tasks for the statistical outputs: (TLGs/TLFs) and the QC checks of SAS program as required according to SOPs
Assist in development of SAS codes and validation of SAS codes for the analysis of clinical study data, generate output tables, listings and graphs in according with the study protocol and the statistical analysis plan (SAP)
Work closely with team to implement protocol methodology and statistical plan to assure timely, accurate, complete and consistent analyses for clinical data
Perform other miscellaneous activities as required
M.Sc plus in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
At least 1-2 years of Biostatistical consulting and SAS programming experience in the pharmaceutical industry or in the field of clinical research
Experience with SAS/Stat at least 1-2 years in clinical trial (BA/BE & early Phase trial)
Knowledge of implementation of CDISC (SDTM and ADaM) requirements
Proficiency with Microsoft Office
Knowledge of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines
Good interpersonal skills, good communication skills
Attentive to details, good initiative and able to work with changing priorities
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Medical Science Liason
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Job Order: GD-757
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