Senior Principal Biostatistician

Novartis Farmacéutica; London; Hybrid; GBP 45,000 - 80,000; Full time

Job summary

An innovative firm is seeking a dedicated professional to provide expert support in clinical development and research projects. This hybrid role involves implementing data analytics reports, guiding development teams, and ensuring compliance with industry standards. The ideal candidate will excel in statistical analysis and automation, contributing to impactful projects that enhance patient care. Join a collaborative environment where your skills will help drive breakthroughs that change lives. If you're passionate about improving health outcomes and thrive in a dynamic setting, this opportunity is for you.

Qualifications

• Expert support in clinical development and research projects.
• Experience with data standards and regulatory compliance.

Responsibilities

• Implement data analytics reports and dashboards for optimal data review.
• Lead authoring user requirements documents and functional specifications.

Skills

Automation

Clinical trials

Computer programming

Metadata management

Statistical analysis

Job description

- 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, and 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. Provide 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

Major accountabilities:

• Drive the implementation of data analytics reports and dashboards for optimal data review by working with users to establish robust specifications and with programmers to implement the best output.
• Translate business requirements into logical models and guide the development team to translate business logic.
• Lead the authoring of user requirements documents, functional specifications, and testing scripts.
• Identify and address needs for optimal data review proactively, working with users and programmers.
• Implement and execute project plans to ensure timely delivery, addressing customer needs.
• Coordinate project resources to meet deadlines.
• Develop and drive user training programs.
• Manage change activities related to new data review tools/reports, including data cleaning, review, and visualization.
• Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.

Key performance indicators:

• Timely execution of projects and data requests
• Feedback from project sponsors and stakeholders
• Adherence to Novartis policies and guidelines
• Metrics and KPIs compliance
• Functional breadth
• Cross-cultural experience
• Operations management and execution

Skills:

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

This role offers hybrid working and will require 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 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 teams that are representative of the patients and communities we serve.

Join our Novartis Network: Not the right 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

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Functional Area: Research & Development

Job Type: Full time

Employment Type: Regular

Shift Work: No

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