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Manager - Real World CDISC Standard
2 weeks ago
Education Requirements:
Advanced degree (master's or Ph.D.) in Life Sciences, Epidemiology, Biostatistics, Public Health, Computer Sciences, Mathematics, Statistics or a related field with applicable experience
Job Related Experience
- Minimum 10 years of experience in the implementation of CDISC standards (SDTM, ADaM, etc.) and with the requirement of submission package , SDRG, ADRG etc.) within the pharmaceutical or healthcare industry.
- Strong knowledge of real-world data sources, including electronic health records (EHR), claims data, and registries.
- Familiarity with regulatory requirements and guidelines related to CDISC standards and real-world data.
- Familiarity with FHIR/OMOP and other common data models is preferred
- Experience in clinical research and development.
- Expertise in R with proficiency in other programming languages such as SAS, or Python.
- Proven track record of leading projects and delivering high-quality results within tight timelines.
- Excellent problem-solving skills and ability to think strategically and innovatively.
- Experience of working in global matrix environment and managing stakeholders effectively
- Experience of using technologies to bring efficiency as well as in simplifying processes
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Demonstrated learning agility, with the ability to quickly adapt to new information and changing environments.
- Commitment to delivering high-quality work and ensuring data accuracy and integrity.
- Strong sense of accountability, taking ownership of tasks and delivering on commitments.
- A growth mindset, open to feedback and dedicated to continuous improvement and development.
- Experience with developing standards for big datasets; Familiarity with the common data models is preferred
- Ability to manage multiple projects and priorities in a fast-paced environment.
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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