Principal Clinical Programming Lead

Job Summary
At Johnson & Johnson, we are dedicated to advancing healthcare innovation by developing smarter, less invasive, and personalized solutions to prevent, treat, and cure complex diseases. Leveraging our expertise in Innovative Medicine and MedTech, we aim to deliver breakthroughs that significantly improve global health outcomes. We are currently seeking a Principal Clinical Programming Lead to join our Data Analytics & Computational Sciences team within Biostatistics. This position is based in India, with opportunities in Hyderabad, Mumbai, or Bangalore, and offers a hybrid work model.

Key Responsibilities
The Principal Clinical Programming Lead will design and develop efficient programming solutions to support complex and critical clinical research analyses and reporting. This includes handling urgent and on-demand requests with precision and timeliness. You will provide technical and project-specific guidance to programming team members, ensuring deliverables meet quality standards and comply with departmental processes.

In this role, you will coordinate and oversee programming team activities, potentially providing matrix leadership across multiple teams. Sharing knowledge and coaching programmers to enhance their technical and analytical skills will be a key focus. You will conduct thorough reviews and contribute to project requirements and documentation, ensuring clarity and completeness.

Collaboration is essential; you will work closely with programming and cross-functional teams to achieve project goals and independently manage escalations when necessary. Additionally, you will oversee programming activities outsourced to third-party vendors, ensuring adherence to scope, timelines, and quality standards through established processes and best practices.

Leading the adoption of new processes and technologies on assigned projects will be part of your responsibilities, working in partnership with departmental technical groups and programming portfolio leads. You will also manage the design, development, validation, and maintenance of clinical databases in accordance with established standards.

Your role will include implementing data tabulation standards, performing data cleaning through programming edit checks and data review listings, and creating data visualizations and listings to support medical and central monitoring activities.

Required Qualifications
Candidates should hold a Bachelor’s degree (e.g., BS, BA) or equivalent professional experience in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or a related scientific discipline. Advanced degrees such as a Master’s or PhD are preferred.

You should have approximately 10–12+ years of experience in the pharmaceutical, CRO, biotech industries, or related fields. A deep understanding of programming practices, including relevant tools and processes for clinical programming, is essential. Familiarity with regulatory guidelines such as ICH-GCP and 21 CFR Part 11 is required.

Proven experience in project, risk, and team management is critical, with a demonstrated ability to lead teams to successful outcomes. Strong skills in planning and coordinating project delivery are necessary. You must be adept at collaborating within multi-functional teams in a matrix environment, managing relationships with stakeholders, customers, and vendors effectively.

Preferred Qualifications and Benefits
While not explicitly listed, advanced degrees and prior leadership experience in clinical programming are highly valued. This role offers the opportunity to lead high-impact programming activities, drive operational efficiency, and mentor programming teams. You will contribute to innovation and process improvements within the department, playing a pivotal role in shaping the future of healthcare through data-driven insights and advanced programming expertise.

Join Johnson & Johnson to be part of a team committed to transforming healthcare and making a meaningful difference worldwide.