Senior Principal Statistical Programmer – Novartis India
Location: Mumbai, India | Experience: 7+ Years | Company: Novartis Healthcare Pvt. Ltd.
Work Mode: On-site | Job Type: Full-time | Job ID: REQ-10031235
Job Summary:
Novartis is seeking a Senior Principal Statistical Programmer to lead statistical programming activities across multiple studies and global clinical development projects. This strategic role involves close collaboration with cross-functional teams and biostatistics to deliver regulatory-compliant datasets, pooled analyses, and programming deliverables for submissions and post-marketing activities. Leverage your expertise in SAS, CDISC SDTM/ADaM, and advanced macros to drive innovation in statistical programming and accelerate the development of life-changing therapies.
Key Responsibilities:
Lead programming across multiple studies or mid-to-large clinical projects (Phase I–IV)
Strategize and coordinate activities of internal/external programmers
Provide programming leadership and supervision to local team members as needed
Develop and review programming specifications, eCRFs, and project-level standards
Ensure standardization for pooling, CRT production, and regulatory submissions
Contribute to the development of analysis datasets, tables, listings, and figures (TLFs)
Act as subject matter expert on programming tools and technical solutions
Ensure all outputs meet quality, audit, and submission standards
Maintain advanced knowledge of statistical software and regulatory requirements
Represent programming in project teams and external collaborations
Required Skills & Qualifications:
Bachelor's/Master's in Statistics, Computer Science, Life Sciences, or related field
7+ years of programming experience in clinical trials or the pharmaceutical industry
Expert-level SAS skills, including macro development and validation practices
Strong experience with CDISC SDTM, ADaM, Define.xml, and eCTD standards
Good understanding of ICH-GCP, regulatory expectations, and study procedures
Proven ability to lead programming teams and mentor peers
Excellent communication and project coordination skills
Perks & Benefits:
Competitive compensation and benefits package
Exposure to global clinical development and submission projects
Leadership and innovation-driven work culture
Access to Novartis career development tools and learning platforms
Be part of a high-impact, inclusive team making a global difference
Company Description:
Novartis Healthcare Pvt. Ltd. is a global biopharmaceutical leader, recognized for advancing innovative science and technology in drug development. With a strong footprint in India, Novartis drives impactful research and regulatory initiatives in support of global healthcare solutions.
Work Mode:
On-site – Mumbai, India
Call to Action:
Ready to lead statistical programming for cutting-edge clinical trials?
Apply today and become part of Novartis' global mission to reimagine medicine and improve patient lives.
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