Company Name:-
GSK

Job Location:-
Bengaluru, Karnataka

Job Summary:-
Site Name: Bengaluru Luxor North TowerPosted Date: May 10 2021
Minimum Education Qualification:
BS in Computer/Math/Statistics/Applied sciences BS in Computer/Math/Statistics/Applied sciences or MS in Computer/Math/Statistics/Applied sciences.

Experience:
6 plus 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 definexml 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.

For complex programs & tools, oversee & coordinate a group of Programming Leads in a matrix setting
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 and/or reviewer/ultimate approver 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 (JPMA/PMDA) and hands-on knowledge on programming data conversions.

Has good communication skills and ability to effectively inform stakeholders of progress and challenges with deliverables.

Ability to have FSP oversight.

Able to cond

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