Statistical Programmer

1 week ago

Hyderabad, Telangana, India Novartis Full time
5 The number of New Molecular Entities (NMEs) approvals of potential blockbusters, which Novartis obtained in 2019 alone.

We advanced a breath of early programs in our pipeline that addresses significant unmet needs and are looking for passionate and enthusiastic Statistical Programmers with expertise in SDTMs, Adams & TFLs, and experience in Regulatory Submissions.

As a part of the Statistical Programming unit, you will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions.

An excellent opportunity to work end-to-end programming from CRF collections through Regulatory submission, you will have an exciting opportunity to learn new technologies (like R) and endorse Statistical Programming as a key contributor in driving the #GO-Digital vision of Novartis.


  • Your key responsibilities:
  • Your responsibilities include, but not limited to:
  • Contribute to statistical programming activities as Statistical Programmer for phase I to IV clinical studies or project level activities.
  • Build and maintain effective working relationship with crossfunctional team. Contribute to assigned parts of process improvement, standardization and other nonclinical initiatives.
  • Review the eCRF, data structures and data review activities. Comply with company, department and industry standards (e.g. CDISC) and processes, create / support the review of programming specifications as part of the analysis plans.
  • Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for studydocuments according to specifications.
  • Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
  • Maintain uptodate knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, ), attend functional meetings and trainings.
  • Under mínimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance.

Commitment to Diversity & Inclusion:

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

Minimum requirements

  • What you'll bring to the role:
  • BE/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field with Ideally 2+ years of work experience in a programming role preferably supporting clinical trials.
  • Basic SAS experience within a Statistical Programming environment to develop and validate deliverables.
  • Basic experience in contributing to statistical analysis plans and/or constructing technical programming specifications.
  • Basic understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP).
  • Good communications and negotiation skills, ability to work well with others globally.
Why Novartis?

  • 769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
    Division
  • Global Drug Development

Business Unit

  • GDO GDD

Country

  • India

Work Location

  • Hyderabad, AP

Company/Legal Entity

  • Nov Hltcr Shared Services Ind

Functional Area

  • Research & Development

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No

Early Talent

  • No

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