Senior Principal Statistical Programmer

4 weeks ago

Mumbai, Maharashtra, 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 Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis

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