About Us
We unite caring with discovery to make life better for people around the world.
Job Description
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.
Key Responsibilities
* Provide strong statistical leadership in the process of drug development.
* Prepare CDISC complied databases, statistical summary table/figures in accordance with a schedule.
* Collaborate with relevant study team members and provide assists from statistical analyst point of view during the development of protocol designs, data analysis plans, and regulatory interactions.
Main Responsibilities
* Statistical Analysis Results Delivery
* Operate in collaboration with global counterparts to prepare CRT packages appropriately meet with regulatory requirements.
* Understand selecting statistical methods for data analysis, then prepare programming codes for delivering analysis datasets and outputs accordingly.
* Collaborate with data management in the planning and implementation of data quality assurance plans.
* Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements.
* Obtain project management skillset to coordinate delivering database and/or statistical outputs.
* Participate in peer-review work products from other statistical colleagues.
* Seek for any innovations towards more efficient working model realized.
Communication Skills
* Collaborate with team members and/or global counterparts to deliver statistical results on time.
* Coordinate workers dedicated to preparing statistical datasets and outputs.
* Presentation of topics related to own responsibilities, such as new tools, methodologies, regulatory requirements, etc.
* Respond to regulatory queries and to interact with regulators.
* Reach out external parties to make environmental shaping happen.
Therapeutic Area Knowledge
Understand disease states and related medical assessments for preparing appropriate definitions and/or specifications that fulfill statistical analysis objectives.
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
* Bachelor's degree in Statistics, Biostatistics, or Computer Science, or relevant certifications.
* 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.
Work Location
Kobe Headquarters Tokyo Branch
Work Scope
This position involves various tasks related to company operations.