Job Description – Lead Statistical Programmer
Company: Novartis Healthcare Private Limited
Division: Development
Business Unit: Innovative Medicines
Location: Mumbai, India (Office-based)
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
About the Role
As a Lead/Program Statistical Programmer at Novartis, you will drive statistical programming activities across multiple clinical studies (Phase I–IV) or medium-to-large projects. You will ensure delivery of high-quality, compliant programming solutions for clinical trial data analysis and reporting, while leading teams, mentoring associates, and representing statistical programming in cross-functional collaborations.
Major Accountabilities
Study & Project Leadership
Act as Trial Programmer across multiple studies or Lead/Program Programmer for medium–large projects.
Make programming-related strategic decisions at the study or project level.
Team Coordination & Management
Coordinate internal and external programming teams.
Provide functional supervision, mentorship, and process guidance to local associates.
Cross-functional Collaboration
Represent statistical programming in study/project teams.
Communicate deliverable status, timelines, scope, and resourcing effectively.
Standards & Compliance
Review eCRFs, data structures, and ensure project-level standardization for efficient reporting.
Adhere to company, departmental, and industry standards (e.g., CDISC, GCP).
Programming & Deliverables
Develop, validate, and deliver datasets and outputs for CSR, regulatory submissions, safety reports, publications, and exploratory analyses.
Ensure quality control, audit readiness, and compliance with analysis plans (e.g., CSPD).
Technical Expertise
Maintain advanced SAS programming knowledge, including macro development.
Stay current with industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml).
External Partnerships
Establish and manage productive relationships with external programming partners.
Process Improvement & SME Contribution
Serve as Subject Matter Expert (SME).
Lead or contribute to process improvements and non-clinical initiatives.
Key Performance Indicators
Quality, accuracy, and timeliness of statistical programming deliverables.
Effective representation of programming in study/project-level meetings.
Impact in mentoring, training, and coordinating programming resources.
Contribution as a programming representative in process improvement initiatives.
Ideal Background
Education
Minimum: BA/BS/MS in Statistics, Computer Science, Mathematics, Life Sciences, or related field (or international equivalent).
Languages
Fluent English (oral and written).
Experience & Professional Requirements
Expert SAS programming skills, including development/validation and advanced macros.
Advanced experience contributing to statistical analysis plans and technical programming specifications.
Strong knowledge of CDISC data structures, standards, and regulatory requirements.
Solid understanding of clinical trial procedures and Good Clinical Practice (GCP).
Proven communication, collaboration, and negotiation skills in a global setting.
Track record as Trial/Lead/Project Programmer, including leading internal and external programming teams.
Ability to mentor and transfer knowledge effectively.
Ideally, 7+ years of experience in statistical programming within clinical trials or the pharmaceutical industry.
Why Novartis
At Novartis, we believe in more than just innovative science—we believe in the power of collaboration. By joining our diverse, inclusive community, you’ll contribute to breakthroughs that change patients’ lives and work with passionate colleagues who inspire and support each other.
Learn more: Our People & Culture
Explore benefits: Benefits & Rewards
Join our talent community: Novartis Network
Accessibility & Accommodation
Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you require support during the recruitment process or to perform essential job functions, please email diversityandincl.india@novartis.com with the job requisition number, nature of request, and your contact details.
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