Statistics Consultant QA - Medicines Quality Organization
Job details
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender. Purpose: The purpose of the Statistics Consultant QA, Medicines Quality Organization (MQO) role is to guide the business to ensure integrity of data, analysis, and systems. The Statistics Consultant QA will focus on the quality of statistical content as it relates to data analysis processes following clinical trial milestones. The Statistics Consultant QA actively consults and develops strategies to mitigate issues associated with clinical trial execution. The Statistics Consultant QA will partner effectively across MQO International and the Statistics, Data and Analytics organizations to achieve positive quality outcomes. Primary Responsibilities: Functional and Technical Expertise
- Expert on regulations and guidelines; provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations.
- Performs on-going risk assessments and evaluation of the quality of data and analysis procedural compliance used in medical research.
- Accountable for the development and implementation of the quality strategy and quality projects for the function.
- Provides input into the design of the medical, safety, and regulatory quality system and leads implementation into the business area(s).
- Works with the business to establish control parameters to understand when systems, validation packages, plans of analysis, or data integrity is at risk.
- Leads the direction of quality by integrating within cross-functional teams, Medical Quality Consultants, Medical Quality Representatives, and Process Owners to ensure consistent practices are employed.
- Provides technical input to help influence the direction to ensure quality is built in.
- Works closely with management and functional teams to resolve complex issues.
- Manages and facilitates audit and inspections and supports audit and inspections in other cross-functional company areas and with external partners.
- Utilizes quality experience to support change management and business transformation in the delivery of the portfolio.
- Leverages experience delivering work products, clinical data, and technical capabilities to discern problems, translate issues, and facilitate problem solving.
- Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the expedited resolution of issues.
- Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of data decisions and/or the portfolio.
- Initiates, drives and coordinates quality improvement initiatives.
- Leads, consults and performs root cause analysis.
- Responsible for quality consultation across the portfolio, involves interactions with all levels across the organizations.
- Key resource in the development of new business process and partnerships.
- Shares key learnings to drive simplification and replicate best practices.
- Leads the development of quality agreements internally and external parties and alliances.
- Acts as quality expert consultant to the business and external parties.
- Works closely with Process Owners, MQS consultants, Training, Business Process Management and other areas to ensure there is awareness of systematic issues and compliance concerns.
- Maintains external focus, exchange with counterparts or competitors and is key member of external committees.
- Bachelors degree in statistics, data science, or comparable experience.
- At least 5 years experience in statistics, data sciences, data analysis, and/or quality.
- Global perspective and working across functional and geographical boundaries.
- Demonstrated understanding of quality management system principles.
- Demonstrated ability to identify root cause and manage difficult global business/quality issues.
- Thorough knowledge of quality systems applicable to all areas of medical research.
- Demonstrated understanding of IT solution development and testing requirements.
- Experience in data analysis, analytics, and presenting data.
- Knowledge of the international regulatory framework.
- Excellent English language skills written and spoken.
- Advanced degree in statistics or data science.
- Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
- Experience with database concepts, text-mining and visualization development.
- Strong knowledge of quality systems.
- Demonstrated ability to operate within large global organizations.
- Project management experience.
- Up to 15% travel required.
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