Senior/ Advisor - Biostatistics

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 Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, 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 these types of studies.

Key Responsibilities:

• The job tasks listed below outline the scope of the position. Based on current business needs, the application of these tasks may vary.

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 conducting the actual analysis once a reporting database is created.

• Collaborate with data management in the planning and implementation of data quality assurance plans.

• Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.

• Participate in peer-review work products from other statistical colleagues.

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 to interact with regulators.

Therapeutic Area Knowledge

• Understand disease states 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.

Minimum Qualification Requirements:

• M.S. or Ph.D. in Statistics or Biostatistics or equivalent with more than 3 Years of relevant experience

Other Information/Additional Preferences:

• Statistics, Biostatistics, or equivalent of field study

• Proficient in the SAS programming language

• Interpersonal communication skills for effective customer consultation

• Teamwork and leadership skills

• Technical growth and application with working knowledge of experimental design and statistics

• 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 strategic thinking

• Business process expertise associated with critical activities (e.g. regulatory submissions)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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