Provides technical leadership, knowledge, experience and expertise by planning, conducting and supervising the Statistics and Data Management function. Provides statistical and data analysis expertise in highly regulated medical diagnostics business. Works independently and in collaboration with scientists, engineers and other statisticians, for the development of statistical methodologies, application tools/programs, and protocols/analyses/reports, for product development and manufacturing release to customers. Prepares written reports and other technical documents and procedures pertaining to statistical methods. Provides statistical consulting and training.
• Provides functional excellence in the areas of statistics, data analysis and data processing for department.
• Applies extensive fundamental and specialized knowledge to the development of protocols, responding to FDA questions, implementing new approaches to automated data processing for clinical trials.
• Conducts or may direct complex technical activities.
• Proposes new ideas and recommends implementation plans leading to enhanced efficiencies and faster review and analysis of data.
• Coordinates and interacts with technical experts within the organization or external experts, as required.
• Develops individuals to their full technical potential. Provides input into the performance review and development plans of individuals within the framework of their current and future assignments.
Specific qualifications required:
• PhD or MS degree with a minimum of 10 years of experience, preferably in the R&D environment. Experience in the Diagnostics business is critical. At least 5 years of experience in an FDA regulated clinical trials environment is required.
• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
• Sound knowledge of statistical methodologies such as analysis of variance, regression, experimental designs, contingency tables.
• Proficiency in SAS.
• Ability to work independently and in project teams.
• Excellent communication skills (written and spoken).
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