Principal Statistical Programmer (Mumbai)

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