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Manager, Statistics - Permanent

Company:
inVentiv
Location:
Somerset, New Jersey, 08873, United States
Salary:
Based on experience
Posted:
December 09, 2016
Description:

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

Qualifications

• 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