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Senior I Clinical Programming Lead

4+ years
Not Disclosed
10 Nov. 7, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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