Associate Director Biostatistics Real World Data

Job Description Summary

Provide highly advanced expert support & functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. 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. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also independently provide timely and professional leadership of special projects that focus on innovative tools and systems. Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support & 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

May lead global teams.

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 utilizing 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?

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired: Automation, Biostatistics, Clinical Trials, Computer Programming, Cross-Functional Teams, Data Analytics, Decision Making Skills, Metadata Management, Statistical Analysis.