REQ-10031208
Nov 28, 2024
India

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.

About the Role

Major accountabilities:

  • 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 -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

  • Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables.
  • Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction

Minimum Requirements:
Work Experience:

  • Biostatistics.
  • Clinical Research Phases.
  • R&D Portfolio Management.
  • Statistical Programming.
  • Data Management & Systems.
  • Regulatory Submissions.
  • Innovative & Analytical Technologies.
  • Clinical Trial Design, Data Review & Reporting.

Skills:

  • Classification Systems.
  • Clinical Trials.
  • Computer Data Storage.
  • Computer Programming.
  • Cross-Functional Teams.
  • Data Analysis.
  • Data Structures.
  • Initiative.
  • Programming Languages.
  • Reporting.
  • Statistical Analysis.

Languages :

  • English.

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Development
Innovative Medicines
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.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10031208

Senior Principal Statistical Programmer

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