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CHStatistical Programmer(SDTM)

2.00 to 7.00 Years   Bangalore   18 Jun, 2019
Covance India Pharmaceutical Services Private Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaAllied Health Services
EmploymentTypeFull-time

Job Description

Job Details

  • 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 clients 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.
Keywords/skillsSDTM Mapping, SAS Programming, MACROS, SAS Data Step Programming, Open CDISC, Specification CreationExperience2+ years of experience in programming in Clinical DomainAdditional Responsibilities
  1. Responsibilities include (but are not limited to): execute and define processes related to setup and support of clinical and/or safety databases; create, present and support training and development of other Programmer Analysts; evaluate and provide feedback on Biometrics software and processes; and ensure effective methods for the design of Case Report Forms (CRFs).
  2. Function as a subject matter expert for the DTP team, proactively sharing expertise with the team as well as colleagues in other functions
  3. Lead the design and build of study databases or lead the study SAS programming activities or other Data Management related system
  4. Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in DTP
  5. Work in a timely manner in accordance with all the activities specified in the agreed study budget, proactively recommending improvements to the programming management team; and make the DTP and study team management aware of any out of scope activities
  6. Provide guidance and training to Level 1 4 colleagues as well as new hires
  7. Perform other duties as required by the Department
Education/QualificationsBachelors / Masters 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.ExperienceMinimum 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the jobDemonstrated 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.

Keyskills :
sciencesystemprogrammingmanagementvalidationresearchconversionsasreportinglinicalcomputerteamcdiscdatastandards

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