Programmer Data Conversion and Standards Jobs in Bangalore at GlaxoSmithKline Pte Ltd

Last Updated: Jul 22, 2021 05:10 IST

JOB DETAILS

Company Name
GlaxoSmithKline Pte Ltd
Job title
Programmer Data Conversion and Standards
Role
Education
Experience
5-8 Years
Salary
Not Mentioned

Job Profile


Job Description :



Minimum Requirements:
BS in Computer/Math/Statistics/Applied sciences or MS in Computer/Math/Statistics/Applied sciences.
Experience:
2to 5 years of programming experience.
Key Responsibilities:
  • Provide innovative solutions, developing and delivering quality data conversion process as well as ensure operational delivery for oncology portfolio.
  • Responsible for the development, validation and review of study & standard programs/macros (Including SAS, PL/SQL.SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data.
  • Responsible for review development and validation of CDASH and SDTM Mapping to support management of data standards and studies.
  • Responsible for the review, development of aCRF, SDRG, Pinnacle 21 annotation and define.xml for various standard or specific studies.
  • Lead the Requirement gathering, development of specifications, Validation plans and performing end to end validation of Standard/Study macros.
  • Support the programmers in trouble shooting and debugging of complex standard and study programs/macros.
  • Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.
  • Act as a technical owner for tools and programs developed in SDTM Programming group.
  • Provide support for implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections
  • Establish and maintain effective working relationships with partners and stakeholders.
  • Act as a coach & mentor for members of the team.
  • Adhere to standards and aware of industry standards and updates.
  • Expert in defensive programming techniques.
  • Extensive knowledge of drug development process and working knowledge of GxP.
  • Knowledge on regulatory submissions and hands-on knowledge on programming data conversions.
  • Has good communication skills.
  • Able to conduct technical interview part of an interview panel.
  • Experience performing data conversion on oncology studies.
  • Experience converting structured and unstructured data from various sources including RAVE/InForm/Veeva as per GSK standards.
  • Experience with CRF automation process for SDTM annotations.
  • Experience reviewing SDTMs for outsourced studies.
  • Develops standards in-line with business demand e.g. CDISC SDTM dataset, Controlled Terminology (CT), Value level definition and metadata (VLD/VLM), mapping/programming specification from raw data to SDTM, GSK in-house data model and other applied standards, supporting documentation and data standards related process documents in GSK.
  • Develop global and study level SDTM mapping/programming spec from raw data
  • Contributes to GSKs compliance to external data standards mandates and reviews industry data standards proposals/changes and provisions feedbackKnowledge / internship projects on data analytics

*LI_GSK
#LI-GSK
#GSKIndia_RD
Our goalis to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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OTHER DETAILS

Key skills
Industry
Pharmaceutical
Summary
Job Description : Minimum Requirements: BS in Computer/Math/Statistics/Applied sciences or MS in Computer/Math/Statistics/Applied sciences. Experience: 2to 5 years of programming experience. Key Responsibilities: * Provide innovative solutions,
Last Date
2021-07-30

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