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Job Details

Programmer Analyst (SDTM Programmer)

Company: Chiltern
Location: India,India - Bangalore
Reference: TSSDTMJUL16
Closing Date: 27 May 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Provide programming or other support and assist CDM managers in daily technical operations. Respond to and solve technical oriented problems in a time

Requirements:

Job Background

  • 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

Requirements
  • 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.
Salary

Competitive

Position Type

Permanent
Full Time

Apply for this job: Programmer Analyst (SDTM Programmer)

Contact Information:

Address:  Chiltern India
No. 58, 01st, 2nd & 06th Floor, H.M Towers, Brigade Road, Bangalore-560025, India
560025
India

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