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Associate Director, Biostatistics and Data Management

Description: We are seeking an Associate Director, Biostatistics and Data Management to provide Biostatistics and Data Management leadership including strategic project planning, clinical study design, approval of data collection forms, database structure, data analysis and reporting, preparation of regulatory documents and interaction with regulatory agencies. This individual will be responsible for managing OXiGENE’s Biostatistics and Data Management vendors. You will be responsible for ensuring proper and consistent positioning of OXiGENE with internal and external constituencies. This position will report directly to the Senior Director, Clinical Affairs. Responsibilities include:

• Direct and manage the overall operations of the Biostatistics and Data Management vendor for multiple projects
• Project Management and contract negotiation with external vendors
• Establish and monitor vendor productivity and performance
• Provide feedback to vendor with respect to quality and productivity
• Work with Program Managers and Clinical Project Teams to ensure seamless and timely delivery of CDM and Biostat services
• Provide guidance and oversight to the vendor in order to successfully execute project work, ensuring that the work is completed within budget, schedule and contract requirements
• Provide statistical expertise at both the study and project level in the areas of protocol, case report form design, database structure, and analysis plans
• Review and approve final documentation developed for the studies (Protocols, Case Report Forms, Annotated Case Report Forms, Data Validation Check Specifications, Statistical Analysis Plan etc.) to ensure appropriateness, accuracy and completeness of the work and documentation
• Ensure the accuracy, completeness, and consistency of clinical databases, analysis tables, listings, and figures
• Participate in meetings with FDA or EU Authorities as necessary
• Ensure that the data management portion of clinical trials and other research involving clinical data is conducted according to applicable regulations
• Oversee CDISC standard development initiative

The successful candidate will have the following attributes:

• Master’s Degree required; Ph.D. degree preferred in related discipline
• 5 - 10 years Statistics/Data Management experience in the pharmaceutical industry or related area
• Experience with external vendor project management and contract negotiation preferred

Please submit resume and cover letter with salary requirements to: jobs@oxigene.com.