Job Title: Senior I Clinical Programming Lead - Mumbai/Bangalore/Hyderabad
Employer: Johnson & Johnson
Location: Penjerla / Mumbai / Bangalore, India
Date Posted: April 25, 2025
Requisition Number: R-002321
Job Function: Data Analytics & Computational Sciences
Job Sub Function: Biostatistics
Job Category: Scientific/Technology
Work Pattern: Hybrid Work
Job Description:
At Janssen Pharmaceutical Companies of Johnson & Johnson, we are committed to advancing the treatment of diseases through innovative data science capabilities. The Senior I Clinical Programming Lead role is pivotal in driving SDTM submission-ready deliverables, including SDTM specifications, datasets, and cSDRG. This role also involves managing interfaces, ensuring efficient clinical data flow, and supporting cross-functional project teams.
Key Responsibilities:
Team Leadership: Provide guidance and oversight for clinical programming activities and lead the execution of key tasks.
SDTM Specifications: Create and review internal Data Review Model (DRM) and SDTM mapping specifications, aCRF, datasets, and related deliverables.
Data Integration: Integrate EDC, eSource, and third-party vendor data into submission-ready tabulation packages.
Programming Expertise: Utilize programming languages (SAS, R, Python, etc.) to create back-end edit checks, data listings, and tables.
Process Improvement: Support the development and implementation of process improvements and new tools.
Cross-Functional Collaboration: Manage escalations and interfaces with various teams, ensuring smooth collaboration on project tasks.
Qualifications:
Education: Bachelor’s degree in Computer, Data, or Life Sciences (Master’s degree preferred).
Experience: 8+ years in a relevant programming role within the pharmaceutical industry.
Technical Expertise: Proficient in SAS, R, Python, or similar languages. Advanced knowledge of SDTM, Define.xml, CDASH, and ADaM preferred.
Project Management: Experience in planning, coordinating, and managing team activities.
Vendor Oversight: Experience with managing external vendors.
Communication Skills: Strong written and verbal communication skills.
Continuous Learning: Ability to stay updated with new technologies and contribute to process innovations.
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