Principal statistical Programmer

  • IT
  • Hyderabad
  • 1 week ago
  • Full Time

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 the study or project level.

May act as a functional manager for local associates, including providing supervision and advice on functional expertise and processes.

Build and maintain effective working relationships with cross-functional teams, able to summarise and discuss the status of deliverables and critical aspects (timelines, scope, resource plan), e.g. as a representative in a study or project-level team.

Ensure project-level standardisation -Provide and implement programming solutions; ensure knowledge sharing.

Act as an 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 a 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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