Job Title:
Senior I Clinical Programming Lead
Location:
Mumbai, India
Function:
Data Analytics & Computational Sciences
Sub-Function:
Biostatistics
Category:
Senior Scientist, Biostatistics (ST6)
Work Pattern:
Hybrid
Date Posted:
November 4, 2025
Requisition Number:
R-029917
About Johnson & Johnson
At Johnson & Johnson (J&J), we believe health is everything. Our strength in healthcare innovation enables us to prevent, treat, and cure complex diseases through smarter and more personal solutions. With leadership in Innovative Medicine and MedTech, we are driving the breakthroughs of tomorrow to profoundly impact global health.
Learn more at www.jnj.com
Position Overview
The Senior I Clinical Programming Lead is responsible for planning, leading, and executing programming strategies across one or more clinical trials or projects. The role ensures delivery of high-quality clinical data outputs compliant with CDISC standards, supports submission activities, and fosters collaboration across internal and external teams.
Key Responsibilities
1. Programming Strategy & Execution
Plan, coordinate, and oversee programming activities following J&J IM and industry standards.
Design and develop complex programs supporting clinical data analysis and reporting.
Lead submission deliverables including CDISC-compliant datasets and reviewer’s guides.
Ensure efficiency, quality, and compliance through technical oversight and process adherence.
Implement metadata-driven approaches to improve data flow consistency across studies.
2. Team Leadership & Oversight
Provide project-specific and technical guidance to programming team members.
Manage deliverables, resources, and timelines ensuring quality and compliance.
Oversee outsourced vendor programming activities to meet agreed scope and performance standards.
Act as a Delivery Unit or Disease Area Expert, supporting standards strategy and submissions.
3. Cross-Functional Collaboration
Collaborate effectively with internal and external stakeholders including:
Internal: Data Management, Central Monitoring, Statistics, Regulatory Medical Writing, Clinical, Procurement, Legal, Global Medical Safety, and Finance.
External: CROs, vendor partners, and industry working groups.
Handle escalations independently and maintain alignment with portfolio leads and management.
4. Clinical Programming & Data Quality
Program edit checks, data review listings, and data visualizations for data management and medical monitoring.
Ensure the use of latest technologies and regulatory-compliant standards in programming.
Create and validate data mapping algorithms, including non-standard conversions as needed.
Support data cleaning, quality assurance, and continuous improvement initiatives.
5. Innovation & Process Improvement
Contribute to process optimization, automation, and technology adoption projects.
Lead or support initiatives improving systems, tools, and standard operating procedures (SOPs).
Education & Experience Requirements
Education:
Bachelor’s degree or higher in one of the following (or equivalent technical field):
Computer Science
Mathematics
Data Science / Data Engineering / Data Analytics
Public Health
Relevant Scientific Discipline
Experience:
Minimum 4+ years of experience in programming and/or clinical data management, preferably in a pharmaceutical or clinical trial environment.
Proven experience in programming coordination, team leadership, and vendor management oversight.
Prior exposure to regulatory submissions and CDISC data standards is essential.
Technical Skills
Required:
Programming Languages: SAS (mandatory); R or Python (desirable)
Strong understanding of data structures, data manipulation, and statistical analysis
Expertise in CDISC Standards (SDTM, ADaM)
Familiarity with clinical R&D, ICH-GCP, and regulatory guidelines
Proficiency with programming tools, project tracking, and documentation
Preferred:
Experience in advanced analytics and data visualization tools
Strong report writing and documentation skills
Understanding of Quality Assurance (QA) and Data Privacy Standards
Ability to manage multiple projects simultaneously with minimal supervision
Core Competencies
Analytical & Critical Thinking
Project & Team Management
Cross-functional Collaboration
Data-driven Decision Making
Communication & Consulting Skills
Digital Fluency and Technological Savvy
Continuous Improvement Mindset
Equal Opportunity Statement
Johnson & Johnson is an Equal Opportunity Employer committed to diversity, equity, and inclusion. We encourage all qualified applicants passionate about data science and clinical innovation to apply.
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Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | North York | Australia | Richmond Hill | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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New Mexico | Ciudad de México |Dubai :
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Riyadh | Najran | Rabigh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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