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CH-Senior Statistical Programmer (SDTM)

Keywords / Skills : SDTM Mapping, SAS Programming, MACROS, SAS Data Step Programming, Open CDISC, Specification Creation, Clinical domain

6 - 8 years
Posted: 2019-06-14

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 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.


Keywords/skills


SDTM Mapping, SAS Programming, MACROS, SAS Data Step Programming, Open CDISC, Specification Creation

Experience

6+ years of experience in programming in Clinical Domain

Additional Responsibilities:
 
  • 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).
  • Function as a subject matter expert for the DTP team, proactively sharing expertise with the team as well as colleagues in other functions
  • Lead the design and build of study databases or lead the study SAS programming activities or other Data Management related system
  • Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in DTP
  • 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
  • Provide guidance and training to Level 1 – 4 colleagues as well as new hires
  • Perform other duties as required by the Department


Education Requirements


Bachelor’s / Master’s degree in Biostatistics, Biotechnology, Statistics, Mathematics, Computer Science or related field of study plus a minimum of 6+ 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.


Education/Qualifications

Degree in a mathematical, computing, life sciences, or related discipline

Experience

Minimum 6+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job


About Company

Covance India Pharmaceutical Services Private Limited
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