Senior Principal Biostatistician

Healthcare Businesswomen’s Association; London; Hybrid; GBP 45,000 - 75,000; Full time

Job summary

An established industry player seeks a dedicated professional to provide expert support in clinical development and research projects. This role involves driving the implementation of data analytics reports, collaborating with programmers, and ensuring high-quality clinical data standards. With a focus on innovation and excellence, the position offers an opportunity to work in a hybrid environment, balancing remote work with essential in-office collaboration. Join a passionate team committed to making a difference in patients' lives through groundbreaking research and development efforts.

Qualifications

• Expert support for clinical development and research projects.
• Experience in data standards and automation technologies.

Responsibilities

• Drive implementation of data analytics reports and dashboards.
• Lead authoring of user requirements documents and functional specifications.

Skills

Automation

Biostatistics

Clinical trials

Computer programming

Metadata management

Statistical analysis

Job description

Job Description Summary

Provide expert support and functional and technical knowledge to ensure scientific integrity/validity for clinical development, early development, and research projects. Participate in the full lifecycle of producing key data and reports, including evaluation of requirements, design specifications, interface with programmers, report programming, validation, and rollout activities. Offer quantitative analytical support and statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. May also support research or other R&D areas.

Responsible for advising and leading the planning, development, and implementation of industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Provide expert support and excellent customer focus to business users and teams on their use of:

• 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, rules, and guidelines

Major accountabilities:

1. Drive implementation of data analytics reports and dashboards for optimal data review by establishing robust user specifications and working with programmers to implement the best output.
2. Translate business requirements into logical models and guide the development team in translating business logic.
3. Lead authoring of user requirements documents, functional specifications, and testing scripts.
4. Identify and address needs for optimal data review proactively, collaborating with users and programmers.
5. Implement and execute project plans to ensure timely delivery and meet customer needs.
6. Coordinate project resources to meet deadlines.
7. Develop and drive user training programs.
8. Manage change activities related to new data review tools, reports, and visualization processes.
9. Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours.

Key performance indicators:

• Timely project and data request execution
• Feedback from sponsors and stakeholders
• Adherence to Novartis policies and guidelines
• Achievement of KPIs

Minimum Requirements:

• Functional breadth
• Cross-cultural experience
• Crises management
• Collaboration across boundaries
• Operations management and execution

Skills:

• Automation
• Biostatistics
• Clinical trials
• Computer programming
• Metadata management
• Statistical analysis

This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.

Why Novartis: Helping people with disease and their families takes more than innovative science; it takes a community of passionate, smart individuals. Join us to collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives. Learn more.

Commitment to Diversity & Inclusion: Novartis is dedicated to building an inclusive, outstanding work environment with a diverse team that reflects the patients and communities we serve.

Join our Novartis Network: Not the right role? Sign up at https://talentnetwork.novartis.com/network to stay connected and learn about future opportunities.

Skills Desired: Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis.