Software and Clinical Data Analyst

3 weeks ago

Mumbai, India Johnson and Johnson Full time
The Software and Clinical Data Analyst in Data Processing Solutions is a high-level, independent technical specialist in clinical data processing technologies to guarantee support required by the Global Development (GD) organization.As a member of the Data Processing Solution team, they will develop in-depth knowledge in clinical data management and programming technologies and take an ownership for projects to either build new or improve existing solutions for the clinical study teams.

This role will be responsible for contributing to development of digital tools and processes supporting clinical trial data integrations, transformations and analyses as well as clinical data standards management.They will support a clinical trail data flow from acquisition systems through landscape of all downstream systems.They will also provide technical support for user communities to resolve complex issues related to data flow, data conversion, metadata and data processing tools.

They will collaborate with data managers, clinical and statistical programmers, clinical teams, biostatisticians, medical writers, technical specialists, and external vendors.This position has no direct reports, however it may provide directions related to addressing problems and/or good practices to user community including external partners.

This role will require building strong internal and external partnerships and will collaborate daily with other team members located around the World.in US, Europe and Asia.It uniquely combines technical and programming skills with a broad exposure to clinical data processing as well as collaboration with multiple functions in clinical development.

The following are examples of the solutions, which may be part of the supported portfolio:

* Data Management Environment (DME) platform;

* Statistical Programming Environment (SCE) platform;

* SAAS based solutions tailored to the life sciences industry;

* Customized web platforms to automate clinical data management activities like clinical standards library management, clinical study specification setup and clinical data validation;

* Data conversion frameworks and tooling to translate raw data into datasets for regulatory submissions and for analysis and for consumption by various downstream applications

Key Responsibilities:

* Implement digital tools, programs, and processes for use by global user community within Global Development

* Mentor and coach in a domain of their expertise

* Operate infrastructure, toolset, and deployment pipelines within platforms supported by Data Processing Solutions team

* Develop scalable and robust code in R or Python

* Write code that is high quality, well detailed, efficient and is easy to maintain

* Drive testing and deployment of software solutions, including implementing of automated testing to ensure solution quality

* Improve operational efficiency by developing automation tools and scripts (e.g.CI/CD automation)

* Provide ongoing solutions support, incl.incident and problem management (L2 ), root cause analysis, and request fulfilment

* Provide technical expertise in process, system, and tool improvement initiatives

* Ensure compliance with regulatory, security and other audit requirements at all times

* Conducts requirements collecting and analysis

* Share expertise to support the clinical data delivery and analysis teams and Clinical Research Organizations (CROs) by coordinating trainings, Question and Answers sessions, and providing direct support when needed

Education:

* A minimum of a Bachelor's degree in Computer Science, Engineering, Science, or related field is required.

Experience and Skills:

Required:

* At least 4 years of meaningful experience in software development and engineering, clinical development or data science field

* High proficiency in Python or R (including R-Shiny).

* Knowledgeable in modern software design patterns and architectural principles

* Must have superb communication, interpersonal, and written skills

* Must be able to work independantly and without supervision

Preferred:

* Knowledge of Data Management or/and Statistical Computing platforms.

* Experience with data wrangling, data processing and data engineering techniques on large datasets.

* Must have a Global Business demeanor and be able to support system and process improvements with operational excellence.

* Must possess ability to think analytically, be quality results oriented and customer focused.

* Technical expertise, preferably in pharmaceutical or a regulated industry, with an experience gained through working with diverse and sophisticated data integration, warehousing and ingestion.

Other:

* Solid understanding of code life cycle management and code repositories is a plus.

* Familiarity with clinical data standards and metadata processing is a plus.

* Position will require 10% travel

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