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Senior Principal Statistical Programmer

7+ years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.