Principal statistical Programmer

2 weeks ago

Hyderabad, Telangana, India Novartis Full time

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

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.

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teamwork, Data Analysis, Data Structures, Initiative, Management Reporting, Programming Languages, Statistical Analysis

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