Biostatistician
6 months ago
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 35,000 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**:
**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.
- 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., Ph.D., or equivalent 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
- 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 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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