Principal Statistical Programmer – Global Drug Development
Location: Mumbai, India | Experience: 5+ Years | Company: Novartis Healthcare Pvt. Ltd.
Work Mode: On-site | Job Type: Full-time | Job ID: REQ-10031239
Job Summary:
Novartis is hiring a Principal Statistical Programmer to lead statistical programming activities across multiple global clinical studies from Phase I–IV. In this key role within the Global Drug Development (GDD) division, you’ll work closely with biostatistics and cross-functional teams to develop validated datasets and outputs for regulatory submissions, CSRs, and publications using SAS, CDISC, and other industry standards. Join a globally respected pharma leader driving data excellence in clinical research.
Key Responsibilities:
Lead programming for pivotal or multiple clinical studies in Phases I–IV
Coordinate activities of internal and external programmers
Develop and validate datasets (SDTM, ADaM) and outputs for submission-ready deliverables
Contribute to statistical analysis plans and technical specifications
Review eCRFs and participate in data review and quality control
Ensure adherence to CDISC standards, regulatory requirements, and internal SOPs
Maintain audit readiness and data accuracy in programming deliverables
Act as SME or lead process improvement initiatives when assigned
Collaborate with global cross-functional teams and communicate deliverable status
Required Skills & Qualifications:
Bachelor’s/Master’s in Statistics, Computer Science, Life Sciences, or related field
Minimum 5+ years of experience in statistical programming for clinical trials
Advanced proficiency in SAS programming in a clinical environment
Solid experience with CDISC SDTM/ADaM, Define.xml, and eCTD standards
Familiarity with regulatory submission requirements (e.g., GCP, ICH)
Excellent communication, coordination, and mentoring skills
Experience leading study-level programming activities and overseeing teams
Perks & Benefits:
Competitive compensation and comprehensive benefits package
Career advancement opportunities in global R&D projects
Access to Novartis learning resources and global talent community
Supportive work culture with emphasis on innovation and collaboration
Company Description:
Novartis Healthcare Pvt. Ltd. is a global leader in pharmaceutical innovation with a strong focus on delivering breakthrough therapies. Its India-based R&D division plays a vital role in advancing data-driven drug development, leveraging world-class talent and cutting-edge technologies.
Work Mode:
On-site – Mumbai, India
Call to Action:
Passionate about data, programming, and clinical research? Join Novartis to shape the future of drug development.
Apply now and accelerate your career in global clinical programming excellence.
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