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**Job Function: **
Data Analytics & Computational Sciences
**Job Sub Function: **
Biostatistics
Job Category:
Scientific/Technology
All Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India
Job Description:
Integrated Data Analytics and Reporting (IDAR)
**Senior I Clinical Programming Lead **
(*Title may vary based on Region or Country requirements)
Job Locations – Hyderabad/Bangalore/Mumbai
Position Summary:
The Senior I Clinical Programming Lead is an experienced programmer with an advanced knowledge of programming languages, has expertise in industry standards, complex data structures and programming methods, having the technical capabilities in leading trial activities in accordance with departmental processes and procedures.
This role is responsible for providing expertise, planning and oversight of one or more programming trial activities of moderate to high complexity. The role makes decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables, and provides leadership, direction, and technical guidance to programming teams.
This role develops cross-functional working relationship with stakeholders to shape processes and practices and contributes expertise to Delivery Unit or departmental innovation and process improvement projects.
The Senior I Clinical Programming Lead position combines the expertise and responsibilities in their respective programming roles, making them an asset to IDAR’s C&SP activities.
Principal Responsibilities:
- Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects.
- Designs and develops programs in support of complex clinical data analysis and reporting activities.
- Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer’s guides.
- Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies.
- Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently.
- Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.
- As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
- May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.
Clinical Programming:
- Ensures the utilization of latest standards and technologies, adhering to regulatory requirements, and creating effective mapping algorithms and Data Review Model (DRM) and designs mapping algorithms for non-standard conversions as needed.
- Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring.
- Responsible for planning, coordination, oversight, and execution of team activities as appropriate and provides technical and project specific guidance to team members.
- Create and/or review internal Data Review Model (DRM) and SDTM mapping specifications, aCRF, datasets, define.xml, cSDRG for stakeholder use (data cleaning, medical review, central monitoring, adaptive decision making, etc.).
- Create back-end edit checks, data cleaning and review listings, tables.
- Independently manages interfaces and escalations with cross-functional project teams.
- Support and/or lead in developing and implementing process, system, and tool improvement initiatives within compliance with departmental processes and procedures.
- Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL, etc.) and apply continuous learning as part of next generation data strategy (Python).
Principal Relationships:
This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities.
- Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.
- Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources.
- External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups.
Education and Experience Requirements:
Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth).
Experience and Skills Required:
- Approx. 4+ years as programming lead experience with increasing responsibility preferably in pharmaceutical/clinical trial environment.
- Knowledge of programming practices (including tools and processes).
- Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
- Expert CDISC Standards knowledge.
- Experience in planning and coordinating programming activities and leading teams.
- Experience working with cross functional stakeholders and teams.
- Experience in vendor management oversight.
- Project management skills and knowledge of team management principles.
- Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.
- Demonstrated written and verbal communication skills.
**Required Skills: **
Preferred Skills:
Advanced Analytics, Analytical Reasoning, Biological Sciences, Biostatistics, Clinical Trials, Data Modeling, Data Privacy Standards, Data Quality, Data Savvy, Detail-Oriented, Good Clinical Practice (GCP), Report Writing, Research Ethics, Researching, Statistical Analysis Systems (SAS) Programming, Statistics, Technologically Savvy