- Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
- Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created.
- Collaborate with data sciences in the planning and implementation of data quality assurance plans.
- Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
- Perform peer-review of work products from other statistical colleagues.
- Influence team members regarding appropriate research methods
- Collaborate with team members to write reports and communicate results.
- Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
- Respond to regulatory queries and interact with regulators.
- Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
- Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
- Ph.D., or equivalent or, M.S. with experience
- Statistics, Biostatistics, or equivalent of field study.
- Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc
- Interpersonal communication skills for effective customer consultation
- Teamwork and leadership skills
- Technical expertise and application with working knowledge of experimental design and statistical analysis
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables
- Resource management skills
- Creativity and innovation
- Demonstrated problem solving ability and critical thinking
- Business process expertise associated with critical activities (e.g., regulatory submissions)
Sr. Principal Statistician - Cork, Ireland - Lilly
Description
We're looking for people who are determined 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. Inhouse 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, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with
disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for clinical studies.
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.
Statistical Trial Design and Analysis
Communication of Results and Inferences
Therapeutic Area Knowledge
Regulatory Compliance
Minimum Qualification Requirements:
Other Information/Additional Preferences:
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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