Job Summary:
Novartis is hiring a Principal Statistical Programmer for its Mumbai office. This full-time, on-site position offers a challenging opportunity to lead statistical programming activities for pivotal clinical trials in global drug development. The ideal candidate will demonstrate strong expertise in SAS programming, CDISC standards, and regulatory requirements, contributing to high-quality data analysis and regulatory submissions.
Key Responsibilities:
Lead statistical programming activities for pivotal or large clinical studies (Phases I–IV).
Coordinate internal and external programming resources for project deliverables.
Develop, validate, and deliver statistical outputs including datasets, tables, and listings.
Collaborate closely with statisticians, data managers, and clinical teams to ensure data accuracy and regulatory compliance.
Review eCRFs, ensure data structure readiness, and participate in data quality activities.
Ensure deliverables meet internal and external regulatory and quality standards.
Contribute to analysis dataset specifications and review statistical analysis plans.
Mentor and guide junior programmers; share knowledge and best practices.
Stay current with industry standards such as CDISC, SDTM/ADaM, and regulatory guidelines (e.g., GCP).
Engage in process improvements and non-clinical project initiatives as assigned.
Required Skills & Qualifications:
Bachelor’s/Master’s degree in Statistics, Computer Science, Life Sciences, Mathematics, or related field.
5+ years of relevant experience in statistical programming, preferably in clinical trials or pharma industry.
Advanced proficiency in SAS programming.
Strong knowledge of CDISC SDTM/ADaM standards and technical specifications.
Experience in developing statistical analysis plans and outputs for regulatory submissions.
Good understanding of regulatory requirements such as GCP.
Excellent communication and coordination skills with global teams.
Experience mentoring or leading programmers is desirable.
Perks & Benefits:
Attractive salary and comprehensive benefits package.
Continuous learning and development opportunities.
Inclusive, diverse, and collaborative workplace culture.
Global exposure in pharmaceutical drug development.
Access to Novartis Life Handbook for detailed employee rewards and programs.
Company Description:
Novartis Healthcare Pvt. Ltd. is a global leader in pharmaceutical research and development, dedicated to reimagining medicine to improve and extend people's lives. With a robust pipeline and cutting-edge drug development practices, Novartis provides exceptional career growth and learning opportunities.
Work Mode:
On-site – Mumbai, India
Call-to-Action:
Ready to lead statistical programming efforts in world-class clinical trials? Apply now and be part of Novartis’s mission to transform global healthcare.
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