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.
Purpose: The statistics officer to the Advanced Analytics and Access Capability team provides strategic technical input and leadership to support the evidence generation plans for Medical Affairs, Access & Reimbursement, and Real-World Evidence across all therapeutic areas (TA). This person, working closely with clinical and statistics design excellence, Statistics TA leads and business units, is responsible for the strategic leadership in the areas of utilization of real world data, clinical data, and other relevant external data to enable novel clinical drug development designs, gain insights on patient population, biomarkers, patient preference etc., drive appropriate integrated evidence generation. This person will also play a key role in finding opportunities to help shape regulatory strategies on the utilization of RWD for purposes of registration where applicable.
This role is responsible for establishing standard methodologies for key analytic capabilities related to real world data research, educating and training statisticians and researchers, and providing analytic consultations for real world research projects to advance the Lilly portfolio across the Business units and Lilly Research Labs (LRL).
Primary Responsibilities: Development and Implementation of Technical Capability Strategy
Responsible for the vision and driving the development of the analytic strategy in the utilization of real-world data and providing data insights for the purposes of enhancing clinical drug development, shaping design elements, and finding opportunities for utilization of real world settings for registration purposes. Be responsible for the medical affairs development strategy and chair clinical review meetings.Responsible to oversee and help implement the analytic strategy, driving sustained technical impact on the Lilly portfolio, consistently delivering on critical assignments producing significant business results.Create a culture of continual learning and drug development focused innovation, maintaining knowledge of developing areas of methodology applicable for real world analytic solutions.Work with design excellence, scientists and medical in the various business units and LRL across different therapeutic areas in setting direction and ensuring alignment of the technical capability strategy with key department and broader company initiatives.Communication & Influence
Work in a team environment, operating with Lilly values including respect for people, a drive for excellence and efficiency, with a focus on our ultimate customer, the patient.Operate with excellent written and oral communication skills, including the ability to develop and both clearly and concisely articulate positions and opportunities to technical and non-technical audiences.Demonstrate the ability to influence key customers, enabling the spread of real world analytic capabilities across the business.Coaching and Development
Develop a group of strong technical project statisticians through coaching and mentoring of key talent.Be a key critical player: Identifying business needs, analytic opportunities, and both engage in and lead cross functional workstreams to establish standard methodologies and automation for quality and resource efficiency.Provide advanced analytics consultations to real world research projects including the design of prospective observational studies, data mining of existing internal and external healthcare databases, and meta analytic / economic modeling for HTA research.Maintain strong expertise with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in rationalizing methods selected.Engage in peer-review work products from other statistical colleagues.Serve as Subject Matter Experts in the area of real world evidence/data/integrated evidence generation and find opportunities in clinical drug development, influencing research projects across the portfolio for a targeted set of analytic capabilities.Technical Leadership
Lead the use of the most efficient and innovative approaches in evidence generation; expertise in analytics appropriate for real world applications such as prospective and retrospective observational studies, causal inference, machine learning, cost modeling, patient focused outcomes, network meta-analyses/indirect comparisons, health technology assessment and reimbursement globally and other regulatory RWE use.Technical leadership in statistical cross-industry and regulatory facing initiatives and/or leadership in key capabilities as demonstrated by strong impact to the portfolio.Leverage technical expertise to work closely with other functions to answer important questions about our products by translating strategic needs into innovative statistical solutions.Develop and engage diverse cross-functional network and an external network with key experts in areas of real world analytics to enhance innovation and break-through thinking in research, development or commercialization to bring value for our employees and customers.Regulatory Compliance
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, local, and departmental policies, procedures, processes, and training.Minimum Qualification Requirements: Ph.D in Statistics or Biostatistics with 10+ years of postgraduate experienceAdditional Preferences: Expertise with real world data analysisProficiency in a statistical programming languageInterpersonal communication skills for effective customer consultationSelf-management skills, creativity, and innovationStrong teamwork and interpersonal skillsDemonstrated problem solving ability and strategic-thinkingDemonstrated leadership skills with ability to accept challenges, influence without authority, and lead in areas of uncertaintyDemonstrated problem solving, learning agility, attention to detail and result oriented behaviors in a fast-paced environment.Strong communication (both verbal and written) and language skillsPassionate about improving technological solutions using new technologiesCreate a team environment that fosters inclusion, innovation, promotes diversity
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