The Manager, Statistical Programming is responsible for managing compound programming activities including the planning, coordination, and execution of the statistical programming functions in support of the clinical research project.
Qualifications/ Required Knowledge/ Experience and Skills:
- Perform hands-on clinical programming activities as well as manages Programming group activities
- Develop programming group's training manuals to promote standard processes and procedures
- Ensure departmental policies, procedures, and standards are in compliance
- Evaluate group's project progress and recommends changes in procedures and objectives
- Collaborate with other function managers and departments (i.e., Safety, Medical Writing, Clinical, Biostatistics, and Quality Management)
- Represent groups in providing solutions to technical problems
- Provide mentoring, on-the-job training, and supervision of new contractors
- Excellent knowledge of SAS programming
- Strong knowledge of relational database structures
- Excellent knowledge of regulatory requirements
- Understanding of the company's products, the competition, and the pharmaceutical industry
- Knowledge of new drug developments in the business.
- Knowledge of the company's work tools, processes, and policies
- Excellent interpersonal and communication skills
- Strong organizational, problem-solving, and decision-making skills
- Be flexible and result-oriented
- Strong computer skills with demonstrated experience in developing statistical base programming and database management
- Bachelors degree or equivalent + 5 years professional work experience in the pharmaceutical industry
- Travel (approximately 10%)
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This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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