Programmer Analyst (SDTM Programmer)
Location: India,India - Bangalore
Closing Date: 27 May 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits
Provide programming or other support and assist CDM managers in daily technical operations. Respond to and solve technical oriented problems in a time
Creating SDTM Mapping specification/aCRFs.
Creation of SDTM datasets by SAS programming.
Create and review SDTM compliant annotated CRFs (aCRF).
Create define xml for submission Data (SDTM) and Validating it.
Create SDTM datasets based on the mapping specification/aCRFs using SAS.
Participate in the development and refinement of SDTM processes.
Extensively use SDTM standards in order to Create Metadata and output SDTM SAS datasets.
Mapping data from different standards to client specific data standards using client’s internal tools based on SAS.
Running and analyzing the Interlinked SAS Datasets.
Author mapping specifications from source (raw) data to target (CDISC SDTM and/or sponsor Define standards).
Develop CDISC SDTM domains utilizing a data conversion tool.
Create data definition files and Case Report Forms annotated to CDISC SDTM.
Run and review Open CDISC reports.
Checking the production datasets with Open CDISC Validator.
Duties & Responsibilities
Please see the Job Descrption
Bachelor’s / Master’s degree in Biostatistics, Biotechnology, Statistics, Mathematics, Computer Science or related field of study plus a minimum of 2 years of SDTM Programming, SAS programming or related experience.
Demonstrated knowledge or experience with: CRO, Life Sciences or Pharmaceutical company; leading programming activities in clinical research; Base SAS®; CDISC standards; FDA, EMA, ICH, GCP and local regulations; and Computer system validation concepts, methodology and its application in pharmaceutical environment.