Summary
About the Role
- Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation, and reporting , health authority response, negotiating with pricing agencies, implement publication strategy, quantitative decision making) to complex, critical studies across assigned programs/indications -Independently lead an assigned program with multiple indications or multiple programs.
- Accountable for key strategic statistical input and influence.
- Independently drive and influence strategy on program development and Health Authority interaction and may play a prominent role representing bio-statistics at HA Advisory Committees and meetings.
- Promote and organize data exploration, synthesis of external data to address risks, trial quality, further understanding, and put results into a broader per-spective.
- Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.
- Propose and implement innovative designs and methods -Plan, prioritize and track project level activities and ensure efficient resource management and effective partnership with vendors -May also represent at internal and external decision boards -At Disease Area / TA/Indication level, as a partner to senior clinical and scientific leadership, drive strategic statistical input to and excellence in development across assigned therapeutic or disease areas/indications.
- CDS -Manage a global team(s) of Clinical Data Standards Specialists providing operational, technical and strategic management and development of teams .
- Accountable for all aspects of Clinical Data Standards delivery within assigned discipline including the strategy & planning to ensure the sucessful development and maintenance of end-to-end s data and reporting standards in one or more disciplines of data acquisition and tabulation, analysis and reporting and/or regulatory data submission across multiple disease/therapeutic areas and drug development phases .
- In collaboration with stakeholder and partner functions across and outside of GDO, accountable for driving standards implementation across the organization and defines and monitors KPIs/metrics, strategies, frameworks, policies, business rules and processes for development, maintenance, deployment and adoption with a strong focus on scientific and regulatory needs.
- lead the technical review and assessment of industry and
- Timely execution of of projects and data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs
Work Experience:
- Geographic Scope.
- People Challenges.
- People Leadership.
- Project Management.
- Functional Breadth.
- Collaborating across boundaries.
- Representing the organization.
- NA.
- English.
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