Sr. Projects Lead, Data Standards and SDTM Delivery

3 weeks ago

Bengaluru, India 14260 GSK India Global Services Private Limited Full time

Years of experience: 6 to 8 Years

Skill Set : Life-science or related medical/clinical area, R programming with SAS and SDTM

Education : Degree/ Masters Computer/Math/Statistics/Applied sciences (or above), or equivalent.

Key Responsibilities

Involves in the development, validation, and review of study & standard programs/macros (Including SAS, CQL, PL/SQL, SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data.

Responsible for the review, development, and validation of SDTM mapping, aCRF, SDRG (Study Data Reviewers Guide), Pinnacle 21, define.xml, data Listings and checks for various standard or specific studies.

Leads the Requirement gathering, development of specifications, validation plans and performing end to end validation of Standard/Study macros.

Implements defensive programming techniques as a part of development lifecycle management of macros/programs/tools.

Project Manages end to end study and ensures deliverables are met on time.

Handles end to end studies (CDM (Clinical Data Management) To Submission).

Support the programmers in troubleshooting and debugging of complex standard and study programs/macros.

Acts as a technical owner and/or reviewer/approver for tools and programs developed in the group.

For complex programs & tools, oversee & coordinate a group of Programming in a matrix setting.

Establish and maintain effective working relationships with partners and stakeholders while assisting them through progress and challenges with deliverables. Adhere to the relevant departmental SOPs (Standard Operating Procedures), corporate policies, regulatory requirements, and industry best practices.

Adhere to standards and aware of industry standards and updates.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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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