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Manager, Statistics - Permanent

Somerset, New Jersey, 08873, United States
Based on experience
January 29, 2018

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