Job Title: Principal Statistical Programmer
Job ID: REQ-10037374
Location: Hyderabad, India (Hybrid)
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time
Company / Legal Entity: Novartis Healthcare Private Limited
The Principal Statistical Programmer is responsible for designing, executing, and ensuring the quality of computer programs that produce statistical outputs for various studies such as Medical Affairs (MA), Interventional and Non-Interventional Studies (NIS), and scientific analytic studies. In addition to programming, this role includes consulting, training, mentoring other programmers, and ensuring operational excellence across projects.
Programming Strategy & Leadership:
Develop efficient project programming strategies using organizational standards and procedures. Lead programming efforts to produce statistical outputs for study reports, publications, and promotions.
Quality Control & Documentation:
Ensure the quality control of all programs, specifications, and statistical outputs. Review and maintain consistent programming-related documentation (e.g., statistical analysis plans, case report forms).
Mentorship & Training:
Mentor junior programmers, provide training on new programming applications, and develop advanced, reusable programming functions for future projects.
Process Improvement:
Actively drive continuous improvement efforts in departmental processes, standards, and utilities, supporting initiatives across Biometrics.
Vendor Management:
Manage outsourcing of programming activities in alignment with vendor management procedures, ensuring timely and high-quality delivery.
Cross-Project Programming:
Oversee the programming for multiple clinical trials and submission activities, ensuring that projects are completed on time and within the required quality standards.
Educational Background:
Graduation/Post-graduation or equivalent in mathematics, statistics, computer science, health sciences, or a related field.
Experience:
Industry Knowledge:
Good understanding of global clinical trial practices, regulatory requirements (e.g., Good Clinical Practice), and statistical programming methodologies.
Technical Expertise:
Experience with CDISC SDTM and ADaM standards is highly desirable.
Novartis aims to improve and extend lives by reimagining medicine. The company believes in the power of its associates to drive the organization toward its ambitious goals. Join Novartis and be part of a community focused on breakthroughs that change patients' lives.
Benefits and Rewards: Learn more about Novartis benefits here.
If this role doesn't align with your experience but you want to stay connected to future opportunities, join the Novartis talent community.
This position offers an excellent opportunity for experienced statistical programmers with a passion for clinical research and operational excellence to contribute significantly to high-quality statistical programming efforts at Novartis.
Join the Novartis Network:
Stay connected and updated on future career opportunities by joining the Novartis talent community.
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