REQ-10075744
מאי 08, 2026
India

תקציר

Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines.

About the Role

Key Responsibilities

  • Lead statistical programming activities for several studies or drive the implementation of data analytics reports. Make decisions and propose strategies at study or project level.
  • May act as functional manager for local associates including providing supervision and advice on functional expertise and processes.
  • Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), e.g. as representative in study or project-level team.
  • Ensure project-level standardization. Provide and implement programming solutions; ensure knowledge sharing.
  • Act as expert in problem-solving aspects.
  • Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc .Leads/co‐leads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community

Essential Requirement

  • Demonstrates strong proficiency in SAS for the analysis and summarization of clinical trial data.
  • Has served as a Trial Programmer or in a comparable programming role with end‑to‑end study responsibility.
  • Possesses experience in the development and/or review of critical study documents, including Protocols, eCRFs, Data Transfer Specifications, SAPs, and mock shells, ensuring consistency with study objectives and regulatory expectations.
  • Shows openness to adopting R and other programming languages, with a willingness to embrace emerging technologies such as AI/ML.
  • Exhibits a comprehensive understanding of CDISC data standards and their application across clinical studies.
  • Minimum 5 years + with Graduation. (MSc preferred)

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Development
Development
India
Hyderabad (Office)
Research & Development
Full time
Regular
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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REQ-10075744

Principal Statistical Programmer

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