[I, Librarian]
  • [Photo] Anna Marie Walsh • May 7, 2003
    Biopure Corporation (Nasdaq: BPUR) is a leading developer, manufacturer and supplier of a new class of pharmaceuticals, called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues as a sterile alternative to red blood cell transfusion. Biopure's oxygen therapeutics possess unique attributes that address many of the medical and logistical issues associated with red blood cell transfusions. The company believes these attributes may enable its products to be used as high-value therapeutics to provide oxygen-carrying support, or an Oxygen Bridge?, in a broad range of potential medical applications.

    The Director of Biostatistics and Data Management will oversee all corporate biostatistics and clinical data management activities. Provide statistical input on the design of clinical trials, selection of clinical endpoints, and sample size requirements.

    Responsibilities Include:
    • Develop statistical analysis plans, perform statistical analyses and manage outsourcing of statistical analyses and clinical data.
    • Work in accordance with all internal and external regulatory bodies including ICH and Biopure SOP?s.
    • Collaborate with clinical researchers in the design of clinical trial selection of clinical endpoints, sample size requirements, protocol development, and case report form design.
    • Develop detailed statistical analysis plans and supervise the development of analysis plans by outside contractors.
    • Manage outsourcing of statistical analysis and reporting of clinical trial data.
    • Manage outsourcing of clinical data management, including coordination of clinical database design requirements, implementation of coding dictionaries, and development of quality control and audit plans.
    • Perform statistical analyses and write statistical reports.
    • Coordinate the integration of clinical trial databases to support creation of integrated summaries of safety and efficiency.
    • Review and approve all clinical trial protocols, case report forms, and final reports.
    • Develop, review, and approve, as needed, SOP?s related to statistics and clinical data management.
    • Represent the company to FDA on matters involving clinical trial design, endpoint selection, sample size requirements, and analysis and interpretation of clinical trial data.
    • Install and maintain statistical software as needed.
    Job Requirements:
    • Requires an advanced degree in Biostatistics related field or equivalent plus eight or more years of clinical trial biostatistical experience. Also must have experience in management of clinical statistical contractors and experience with clinical protocol design, statistical planning, and NDA statistical sections.
    • The ability to ensure and adhere to budgets, schedules and performance standards.
    • Must possess excellent communication skills in order to regularly interact with both senior level managers and lead line staff. Must possess good oral and written communication skills and should exercise tact and diplomacy in sensitive situations.
    • Must be able to direct and control several functional areas and or initiatives concurrently.
    • Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
    Please fax, email or mail resume to:
    Human Resources
    Biopure Corporation
    11 Hurley St.
    Cambridge, MA 02141
    Fax: 617-234-6830
    Email: resume[at]biopure.com
    Web Site: http://www.biopure.com

Discussion forums: Opportunity: Director of BIOSTATISTICS and DATA MANAGEMENT--Cambridge, Mass.

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Senior Director, Clinical Data Management
Submitted by Nobody ; posted on Monday, October 20, 2003
I'm searching for a Sr. Director Clinical Data Management and I.S. My client is a pharmaceutical company located in Seattle, WA . This Senior Executive will run the entire division which is responsible for the Clinical Data and Information Services work related to all phases of the clinical trials/drug development process. A global strategic position. Candidates must have senior executive skills and experience building and managing a big clinical data shop. Excellent compensation and relocation. Would you know of anyone that may have an interest? Tom O'Bremski Executive Recruiter Tanner & Associates 425-814-2646 transpacific@comcast.net

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Senior Director, Clinical Data Management
Submitted by Nobody ; posted on Monday, October 20, 2003
I'm searching for a Sr. Director Clinical Data Management and I.S. My client is a pharmaceutical company located in Seattle, WA . This Senior Executive will run the entire division which is responsible for the Clinical Data and Information Services work related to all phases of the clinical trials/drug development process. A global strategic position. Candidates must have senior executive skills and experience building and managing a big clinical data shop. Excellent compensation and relocation. Would you know of anyone that may have an interest? Tom O'Bremski Executive Recruiter Tanner & Associates 425-814-2646 transpacific@comcast.net

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