Lead / Senior Lead, RWE (Bio Statistics Specialist)

Role Purpose

The Data Science Specialist in the Real-World Evidence & Evidence Excellence (RWE&EE) team is responsible for providing strategic guidance and analytical approaches to evidence generation initiatives, particularly in the areas of clinical research, post-marketing studies, real-world data, and evidence. They will act as a partner to the Medical Franchise teams, Health Economics and Outcomes Research (HEOR) team, and Global Drug Development (GDD) to lead evidence generation efforts and contribute to the development of integrated medical plans and early medical strategies within Novartis.

Major Accountabilities

• CONTRIBUTE TO THE DESIGN AND ANALYSIS OF RWD

o Co-lead Data generation planning, implementing and delivering high quality, scientifically robust observational and / or Clinical trial design (i.e. target population, protocol development, sample sizing)

o Evaluate and assess strengths and weaknesses of external Real World Data sources for advancing the data strategy for a given therapeutic area.

o Design a fit-for-purpose analysis plan by considering validity and generalizability of data and results, assess effective ways of delivering the results to maximize impact and interpretability.

o Operate in collaboration with study personnel to provide statistical considerations on study design.

o Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the data analysis.

o Maintain accuracy with respect to statistical methodology, to maintain proficiency in applying new and valid methods, and to be competent in justifying methods selected.

o Ask the right scientific questions, understand the evidence needs and make recommendations on fit-for-purpose data and analytics solutions.

o Leverage RWD and technology to propose solutions for enhancing medical practice and patient outcomes (e.g., engagement platforms, TPO dashboard etc.)