Manager - Real World Programming

GSK India

12 - 14 years

35 - 40 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Procurement Statistical programming Manager Quality Assurance Clinical trials Oncology Life sciences Manager Quality Control Public health SQL Python

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 (Masters 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

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