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>Director BioStatistics
>
>Biopure Corporation is a biopharmaceutical company founded in 1984 that has
>become a leading developer and manufacturer of a new class "oxygen
>therapeutics". Biopure's "oxygen therapeutics" are based upon proprietary
>technology including patented processes for producing ultrapure, chemically
>crosslinked and polymerized hemoglobin solutions that are stable at room
>temperature and compatible with all blood types.
>
>This Director BioStatistics will be a statistical resource for the clinical
>trials -related sectors of the company.
>Principal Duties & Responsibilities:
>* Oversees 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.
>* Develop statistical analysis plans, perform statistical analyses and
>manage outsourcing of statistical analyses and reporting of clinical trial
>data..
>* Work in accordance with cGMP principles, ICH guidelines and Biopure
>SOP's.
>* Collaborate with clinical researchers in the design of clinical
>trials, selection of clinical endpoints, sample size requirements, protocol
>development, and case report form design.
>* 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/review statistical reports.
>* Coordinate the integration of clinical trial databases to support
>creation of integrated summaries of safety and efficiency.
>* Develop, review, and approve, as needed, SOP's related to statistics
>and clinical data management.
>* Represent the company to FDA and other regulatory authorities on
>biostatistical issues.
>* Collaborate with IT to install and maintain statistical software as
>needed.
>* Direct statistical activities in support of manufacturing and
>process technology departments.
>* Principal Duties & Responsibilities:
>* Oversees 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.
>* Develop statistical analysis plans, perform statistical analyses and
>manage outsourcing of statistical analyses and reporting of clinical trial
>data..
>* Work in accordance with cGMP principles, ICH guidelines and Biopure
>SOP's.
>* Collaborate with clinical researchers in the design of clinical
>trials, selection of clinical endpoints, sample size requirements, protocol
>development, and case report form design.
>* 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.
>* Develop, review, and approve, as needed, SOP's related to statistics
>and clinical data management.
>* Represent the company to FDA and other regulatory authorities on
>biostatistical issues.
>* Collaborate with IT to install and maintain statistical software as
>needed.
>* Direct statistical activities in support of manufacturing and
>process technology departments.
>Other duties and responsibilities as assigned.
>Please fax, email or mail to: Human Resources
>Biopure Corporation, 11 Hurley St., Cambridge, MA 02141 Fax: 617-234-6830
>Email: [log in to unmask] Website: www.biopure.com
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