Job Description
Seeking a Clinical Statistician to lead clinical development programs, design studies, and analyze data for clinical trials, with a strong understanding of patient and business needs.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, with a diverse team of over 1,600 employees across 38 nationalities.
Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension, and life assurance benefits, as well as in-house people development services and wellbeing initiatives.
The company is committed to diversity, equity, and inclusion, catering to all dimensions, including ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender.
Eli Lilly Cork partners with the Access Lilly initiative to make its physical and digital environment accessible and inclusive for all.
Job Description:
- Statistical Trial Design and Analysis: Collaborate 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.
- Communication of Results and Inferences: 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.
- Therapeutic Area Knowledge: 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.
- Regulatory Compliance: 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.
- Statistical Leadership and Teamwork: Introduce and apply innovative methodology and tools to solve critical problems.
- Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions.
- Lead projects independently and work effectively across functions.
- Apply technical expertise to influence business decisions.
Requirements:
- M.S. or Ph.D. in Statistics or Biostatistics.
- 5 years of experience in clinical development programs.
Preferred Qualifications:
- Proficient in statistical programming languages/software such as SAS, R, Spotfire, Win BUG, 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).