Site Name: India - Karnataka - Bengaluru
Posted Date: Jun 21 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 .
6 plus years of programming experience
- 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 conduct technical interview part of an interview panel.
- Experience performing data conversion on large phase 3 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 review and co-ordination of SDTM review on outsourced studies.
- Experience understanding SDTM harmonization for pooled analysis.
- Contributes to GSKs compliance to external data standards mandates and reviews industry data standards proposals/changes and provisions feedback.
- Conducts risk analysis for internalization of industry standards and changes to those standards.
- Develops standards in-line with business demand e.g. CDISC SDTM dataset, Controlled Terminology (CT), Value level definition and metadata (VLD/VLM)
- Ability to perform the final review
- Excellent in Project Management for end to end study . Experience in handling end to end studies (CDMTo Submission) from the Project Management will be added advantage
- Experience in collecting the Project Management Reports
Our goal is 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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