Senior Clinical Project Statistician-ARS

2 weeks ago

Cork, Cork, Ireland Eli Lilly and Company Full time

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.

Senior Clinical – Project Statistician

Organisation Overview:

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. 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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

Purpose:

As a Clinical Statistician, you will be a leader in our clinical development programs. You will understand the patient and business needs and then develop or assist 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.

Primary Responsibilities:

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:

  • 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.

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.

Minimum Qualification Requirements:

  • M.S., Ph.D. in Statistics or Biostatistics and 5 years experience.

Other Information/Additional Preferences:

  • 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).
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