REQ-10041556
Mar 18, 2025
United Kingdom

Summary

-Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines.

About the Role

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.


To do this, we are optimizing and strengthening our processes and ways of working. 

We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.


We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.


Apply today and welcome to where we thrive together!

The Role

Our Scientists are responsible for providing strong statistical support for contributing towards the design and analyses of real-world evidence studies, including patient preference studies. This includes contributing towards methodology in both areas and utilize your statistical and programming expertise. You may also have opportunities to contribute towards the regulatory context from such studies.

This role offers hybrid working, requiring 3 days per week in our London office.

Key Accountabilities:

  • Designing, analyzing, managing non interventional studies (NIS) including Patient Preference Studies (PPS) and collaborating with multiple stakeholders to deliver critical analyses
  • Representing the real-world data (RWD) statistical expertise within Global Medical Affairs and Patient Engagement
  • Contributing towards any regulatory documents when required for such studies
  • Developing clear and concise study protocols, analysis plans, and reports
  • Providing scientific direction for and/or directly conducting data analysis, statistical model development, and statistical programming (preferred languages R and/or SAS
  • Training others (through support) on methods and principles relating to RWD studies, including PPS
  • Managing vendors relating to any statistical deliverables
  • Representing Novartis at meetings, internal or external on aspects related to NIS (including PPS)
  • Developing internal processes for design reporting and execution of NIS (including PPS)
  • Keeping abreast of latest methods and looking for opportunities to develop and implement innovative methodologies and evaluating risks and opportunities for NIS/PPS projects

Your experience:

  • MSc Statistics or equivalent with at least 5 years of work experience or PhD (in Statistics or equivalent) with at least 3 years of work experience with expertise in RWD analysis methodology
  • Has advanced knowledge of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas.
  • Strong data analytic proficiency R (advanced skills required), other languages a plus (SAS, STATA, or similar programming language)
  • Ability to handle multiple projects successfully with scientific rigor
  • Intellectual curiosity and independence to include the ability to self-start and self-teach
  • Proactivity, responsiveness, and the ability to balance shifting priorities to ensure that timelines and objectives are met, and expectations are exceeded
  • Able to forge and manage significant relationships with internal and with external stakeholders
  • Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.

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(link is external)

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.

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external) 

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(link is external)

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards(link is external)

Development
Innovative Medicines
United Kingdom
London (The Westworks)
Research & Development
Full time
Regular
No

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

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10041556

Senior Principal Biostatistics Real World Data

Apply to Job(link is external)