Manager - Real World Programming
Bengaluru Luxor North Tower, India
GSK
At GSK, we unite science, technology and talent to get ahead of disease together
Key Responsibilities
Accountable for planning and executing statistical programming and quality control (QC) of all studies and real-world data insights as relevant.
Full accountability for programming of simple to moderately complex studies.
Maintain a 'first time right' mindset to ensure high-quality deliverables.
Accountable for the accuracy and reliability of programming outputs.
Implement and uphold quality assurance processes to maintain high standards.
Create specification documents for programming.
Drive stakeholder engagement
Assume the role of Programming Lead for a specific disease area and provide technical leadership to project teams while working hands on.
Assigns work being cognizant of project needs and an individual skillset, bandwidth and interest areas of a resource
Support team navigate the technical issues within a project
Develop and maintain programming standards and best practices within the disease area.
Ensure adherence to regulatory and company standards in statistical programming activities
Identify opportunities for process improvements and implement innovative solutions to enhance efficiency and quality, while driving the adoption of advanced programming tools, technologies, and methodologies
Collaborate with study teams to ensure the appropriate application of CDISC standards for RWD in submissions as needed, while demonstrating expertise with different guidelines and staying informed about the evolving regulatory landscape, requirements, and industry standards concerning the use of RWD in clinical trials and real-world evidence studies.
Communicate effectively within RWDMA and outside (e.g. CP) to address project needs and challenges, and represent the statistical programming team in meetings and discussions with senior management and external collaborators.
Lead CDISC-related tasks for non-interventional studies (NIS), external control arms, etc. as relevant.
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
Experience working with RWD for use in pharmacoepidemiology research with good practical knowledge in biostatistics applied to clinical/epidemiological research.
Expertise in some of the most commonly used Real World Databases within Real World landscape
Expertise in R with proficiency in other programming languages such as SQL, or Python.
Passionate about working hands-on with data, and proficient in manipulating large, complex datasets and preparing supporting documentation for quality control (QC)
Experience of working in global matrix environment and managing stakeholders effectively
Experience of using technologies (AI/ML, NLP, Deep learning models etc) to bring efficiency as well as in simplifying processes
Growth mindset and a commitment to continuous learning and development.
Excellent leadership, communication, and interpersonal skills.
Excellent problem-solving, communication, and interpersonal skills.
Innovative mindset and willingness to challenge status quo, solution-oriented mindset
Familiarity with commonly used statistical and epidemiological concepts
Fluent in written and spoken English to effectively communicate and able to articulate complex concepts to diverse audiences
Knowledge of regulatory requirements and industry standards for real-world evidence studies.
Experience with developing standards for big datasets; Familiarity with the common data models and knowledge of CDISC is good to have
Ability to manage multiple projects and priorities in a fast-paced environment.
Ability to do complex programming
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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Tags: Biostatistics CDISC Deep Learning Machine Learning Mathematics NLP Python R Research SQL Statistics
Perks/benefits: Career development Startup environment
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