
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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