Biostatistics department is responsible to provide high quality biostatistics services at study level as well as asset or submission level data reporting. Manager, biostatistics is a management level position responsible for oversight and management of biostatistics staff and assignments.
• Develops analysis plans, ensuring statistical methods and corresponding details are appropriate and sound, consistent with the study design, and sufficiently detailed for programming implementation
• Analyzes data from clinical trials or scientific experiments to meet objectives of the study protocol
• Independently applies and implements basic and complex statistical methodology to analyses
• Independently identify and anticipate technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research
• Approves and implements alternative analysis strategies or other recommendations to address these issues
• Works with project team to develop strategy for data presentation and scientific/statistical arguments
• Ensures consistency of data presentations among reports within a project with supervision
• Prepares oral and written reports that effectively communicate results of scientific research to the project team, management, or other stakeholders
• Ensure consistency in presentation, inference, and adherence to accepted report guidelines and publication practices
• Ensures as applicable that guidance and template formats for all data presentations and reporting are closely followed
• Performs peer review for protocol, analysis plan, study report, and other major deliverables, publications
• Responsible for providing critical review to enhance quality and accuracy of data presentation and scientific/statistical arguments
• Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines
• In collaboration with Statistical Programming or their designee, ensures that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements
• Demonstrates a high degree of responsibility in maintaining Statistics/Biometrics department standards, GxP compliance, and best operating practices
• MS or PhD in Statistics, Biostatistics or mathematics
• At least 2-4 years (PhD) or 5-7 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required
• High degree of technical competence and effective oral and written communication skills
• Competent in experimental design, descriptive and inferential statistics, biometrics/biopharmaceutical applications and computer programming
• Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
• Embraces the ideas of others, nurtures innovation and manages innovation to reality
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