Job Description Summary

-Biostatistics -Influences and drives statistical strategy/innovation at advanced expert-level directly taking part in cross-functional collaboration and decision making for multiple programs, across multiple indications/therapeutic/disease areas within (pre/early/full) clinical development and/or medical affairs. Responsible for leading and integrating input from different quantitative scientists, impacting clinical development, health authority interactions. Represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions. -CDS -Supports Head CDS in setting the standards and automation strategy across Novartis. Manage a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks, policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape.

Job Description

Major accountabilities:

• 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

Key performance indicators:

• 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

Minimum Requirements:
Work Experience:

• Geographic Scope.
• People Challenges.
• People Leadership.
• Project Management.
• Functional Breadth.
• Collaborating across boundaries.
• Representing the organization.

Skills:

• NA.

Languages :

• English.

Skills Desired