Chc Lead Associate Regulatory Affairs

With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We&rsquore harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people.
Now, we&rsquore calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.
Welcome to the relentless pursuit of better.

We are inviting applications for the role of CHC Lead Associate - Regulatory affairs

As part of the Real Word Evidence and Behavioural Science Team, the Data Analyst/Programmer will execute statistical and computational programming and analytics for Observational -, Real-World Evidence and other studies across the CHC product development pipeline.
He/she will use large-scale patient databases and high-performance computing to generate conventional analytics evidence and insights for the Science hub, Growth hub, and business strategy
The Data Analyst/Programmer will work closely with RWE Engagement Leads, Data & Analytics Lead, Data scientists, Statisticians, and other project leaders to contribute to projects addressing questions posed by the CHC teams that will be used to make decisions to develop and commercialize the most impactful medicines
Responsibilities
. Extract, manipulate, and analyse data from real world including medical claims, EHR, patient%27s registries, national surveys, clinical and other emergent data types
. Perform statistical analysis, generate analytic reports, tables, listings, graphics, and slides
. Ensure statistical outputs are produced in an efficient manner and perform quality checks
. Provide technical and analytical input on study design, analysis plans and results interpretation where necessary.
. Review the study concept, protocol design, analysis plans and other study-related documents.
. Provide accurate and timely deliverables
. Hands on implementing analytical solutions and pipelines to reduce the analytical burden
. Participate in developing and improving analytical process standards and best practices

Qualifications we seek in you!
Minimum qualifications
. An advanced educational degree (Bachelor&rsquos, master%27s, or PhD) in Statistics, Epidemiology, Public Health, Computer Science, or related field
. Relevant year of experience with programming language (Python, R, SQL) to transform data and perform statistical analysis
. Relevant year of experience using biostatistics to perform formal epidemiologic or outcomes research studies describing patient populations, health care utilization, treatment patterns, and effectiveness or safety outcomes
. Relevant year of experience with real world data (medical claims, electronic health records, etc.)

Preferred Qualifications/ Skills

. Knowledge of Regulatory Affairs/Operations domain and regulatory requirements is a plus
. Prior experience in the execution of analytics on big data stacks (HDFS, Spark, NoSQL databases).
. Experience with reproducible and collaborative technology platforms (e.g., GitLab, GitHub)
. Experience in/knowledge of some data visualization technologies (Tableau, PowerBI, Qlik sense, shiny, )

Skills and capabilities
. Advanced statistical programming skills in python or R to solve complex programming tasks.
. Knowledge of SAS is a plus.
. Ability to learn new programming techniques and data structures quickly and effectively
. Capacity to seamlessly assimilate to new projects is required
. Knowledge of statistical and epidemiological methods applied in Real World studies
. Ability to comprehend analysis plans which may describe observational research and statistical programming methodology to be programmed
. Readily adapt to new environment, technologies, and processes
. Ability to deal with frequent changes, delays, or unexpected events
. Teamwork and collaboration skills

Language skills
. Fluent spoken and written English

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training.

Key Skills