Principal Project Lead, SDTM & Programming

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Principal Project Lead, SDTM & Programming
G
GSK
Bengaluru, Karnataka
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17 hours ago
Full–time
Site Name: Bengaluru Luxor North Tower
Posted Date: Sep 15 2023

Key Responsibilities (Mandatory Skills required):

1. Strong at SDTM and Programming (preferably R primarily, SAS secondary).

2. This will be Bangalore office based. (2-3 days week).

• Provide innovative solutions, developing and delivering quality data conversion process as well as ensure operational delivery across multiple therapeutic area.
• Lead, develop, validate and review study & standard programs/macros (Including R-Programming, or SAS, Python) that support standard and study-level conversion of clinical trial data.
• Responsible for review, development, and validation of aCRF, SDTM mapping, define.xml, Pinnacle 21, SDRG, data Listings and checks 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.
• Expert knowledge in defensive programming techniques.
• Support the programmers in troubleshooting and debugging of complex standard and study programs/macros.
• Act as a coach and mentor to develop technical competencies.
• For complex programs & tools, oversee & coordinate a group of Programming Leads.
• Excellent in Project Management for end-to-end study (CDM To Submission) and ensure deliverable are met on time.
• Provide input to CAPA and response to audit findings.
• Identity and implement the area of improvement in the existing process and bring futuristic innovative solutions.
• Lead and own solutions for automation.
• Be a technical developer and reviewer for tools and programs.
• Act as a primary point of contact for external stakeholders (Data Management, Data Acquisition, Clinical Programming etc.) w.r.t programming activities (SDTM / CQL / R- Programming).
• Overseeing FSP studies and review their work.
• Ability to effectively communicate with the stakeholders of progress and challenges with deliverables.
• Able to conduct technical interviews.
• Establish and maintain effective working relationships with partners and stakeholders.
• Adhere to quality metrics and assurance.
• Compliant with departmental expected policies and procedures.
• Anticipates and discusses action items around process with Reporting Manager.
• Manage potential risk identification and mitigation in terms of process.
• Exploring and visualizing data to gain an understanding and analyse the patterns and trends in data distribution that could impact the process and performance.
• Ability to analyse the ML algorithms that could be used to solve a given problem and ranking them by their success probability.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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