Key requirements

• Lead statistical programming activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
•  Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level.
• May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes.
• Key skills HTA, RWE, HE OR, R/R-Shiny, SAS, Statistics, Leadership
• Collaborate with cross-functional teams, discuss status of deliverables and critical programming aspects (timelines, scope, resource plan)
• Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Act as subject matter expert or as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

This role will be hybrid, requiring 3 days per week in our London office.

Your Experience

• Fluency in English with strong negotiation skills, ability to work well with others globally and influence. BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field

• Must have strong programming skills in R/R Shiny. Python is desirable (and SAS optional). Demonstrated knowledge of data visualization, exploratory analysis.
• Exposure to late phase studies & Real-World Evidence. (for strong candidates we can offer training)
• Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry. Experience in Health Technology Assessment /HEOR is preferable
• Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures)
• Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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