Manager, Clinical Programming Job in Rockville 20852, Maryland US
Roles and Responsibilities
Manages compound programming activities including the planning, coordination, and execution of the statistical programming functions in support of the clinical research project.
85%
· Manages Data Analysis Programming group activities.
· Develops Data Analysis Programming group's training manuals to promote standard processes and procedures.
· Ensures departmental policies, procedures, and standards are adhered to.
· Evaluates group's project progress and recommends changes in procedures and objectives.
· Collaborates with other function managers and departments (i.e., Safety, Medical Writing, Clinical, Biostatistics, and Quality Management) to ensure that their requirements are satisfactorily fulfilled.
10%
· Represents groups in providing solutions to technical problems.
· Coordinates validation of analyses generated by Analysis Programming Group.
· Provides mentoring, on-the-job training, and supervision of new contractors.
5%
· Assists in departmental and clinical budgetary activities.
Requirements:
Knowledge:
· Requires knowledge of SAS programming, as well as relational database structures and data management processes
· Knowledge of regulatory requirements as they relate to programming and validation.
· Knowledge of company's products, tools, and processes as well as clinical trial process development.
Skills:
· Strong computer skills with demonstrated experience in developing statistical base programming and database management.
· Master's degree in Computer Science with 5 years of SAS experience and 3 years of experience in pharmaceutical industry.
Apply Online at:
https://2xrecruit.kenexa.com/kr/cc/jsp/public/EmailJobDetail.jsf?npi=592BD0535B5F57261EE563929442C841rand=9524D25B8879D3B16DC8109564AB5094
Company Description:
Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of its patients around the world with a strong commitment to research and development in the areas of cardiovascular, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders.