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Senior Principal Statistical Programmer

NovartisNovartis·Pharmaceuticals

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Posted

37 days

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About the role

Job Description Summary

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.


 

Job Description

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 6 years + with Graduation. (MSc preferred)


 

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis
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Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.

Synthesized from recent postings & public sources

What's promising

  • Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
  • The company offers a wide range of global career opportunities across various fields.
  • Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

  • Regulatory challenges can impact the speed of drug approval and market entry.
  • High competition in the pharmaceutical industry requires constant innovation to maintain market position.
  • Complex organizational structure may slow decision-making processes.

Why Novartis

  • Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
  • The company emphasizes a diverse and inclusive workplace culture across its global operations.
  • Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

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About Novartis

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.

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