Project Statistician

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Job details

Company overview

We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world's leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.

Responsibilities

Responsibilities:

• The Project statistician provides strong statistical leadership in the process of drug development, 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 Project Statistician is also responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.

Other Responsibilities Include But Not Limited To The FollowingStatistical 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.

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

Basic Requirements:

• M.S. or Ph.D. in statistics or biostatistics

Other Information/Additional Preferences:

• Rich experiences in healthcare field as a statistician with science background such as mathematics or epidemiology.
• Statistical and methodological knowledge 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

Salary

5.5 - 7 million yen

Location

Hyogo