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Senior Project Lead SDTM Delivery Programming Specialist

1 month ago


Bengaluru, Karnataka, India 14260 GSK India Global Services Private Limited Full time
Key Responsibilities

As a Senior Project Lead for SDTM Delivery Programming, you will be responsible for the development, validation, and review of study and standard programs/macros that support standard and study-level conversion of clinical trial data.

  • Develop, validate, and review study and standard programs/macros, including SAS, CQL, PL/SQL, SPOTFIRE, R-Programming, and Python.
  • Lead the requirement gathering, development of specifications, validation plans, and end-to-end validation of standard/study macros.
  • Implement defensive programming techniques as part of the development lifecycle management of macros/programs/tools.
  • Project manage end-to-end studies and ensure deliverables are met on time.
  • Handle end-to-end studies from CDM to submission.
  • Support programmers in troubleshooting and debugging of complex standard and study programs/macros.
  • Act as a technical owner and/or reviewer/approver for tools and programs developed in the group.
  • Oversee and coordinate a group of programmers in a matrix setting for complex programs and tools.
  • Establish and maintain effective working relationships with partners and stakeholders while assisting them through progress and challenges with deliverables.
  • Adhere to relevant departmental SOPs, corporate policies, regulatory requirements, and industry best practices.
Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.

So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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