Biostatistical Researcher
5 days ago
We are seeking a Clinical Development Specialist to join our team at Eli Lilly and Company. As a Clinical Development Specialist, you will be responsible for providing statistical leadership in the process of drug development, preparing CDISC compliant databases, statistical summary tables/figures, and collaborating with relevant study team members to provide assists from a statistical analyst's point of view.
Main Responsibilities:
1. Operate in collaboration with global counterparts to prepare CRT packages that meet with regulatory requirements.
2. Understand selecting statistical methods for data analysis, then prepare programming codes for delivering analysis datasets and outputs accordingly.
3. Collaborate with data management in the planning and implementation of data quality assurance plans.
4. Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements.
5. Obtain project management skillset to coordinate delivering database and/or statistical outputs.
6. Participate in peer-review work products from other statistical colleagues.
7. Seek for any innovations towards more efficient working model realized.
Required Skills and Qualifications:
M.S. in statistics, biostatistics, or computer science, or rich experiences in healthcare field as a computational statistician with science background such as biology or epidemiology.
Statistical/methodological knowledge and computational skill in clinical development, epidemiology, or related field.
Regulatory knowledge of clinical trial methodology and statistics.
Ability to build relationships with individuals and teams.
Good communication and presentation skills in both English and Japanese.
Therapeutic Area Knowledge:
Understand disease states and related medical assessments for preparing appropriate definitions and/or specifications that fulfill statistical analysis objectives.
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