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Clinical Statistician
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 Clinical Statistician will be a statistical resource for the clinical trials -related sectors of the company.
Responsibilities Include:
- Statistical consultation and analysis of data from Phase 2 and Phase 3 clinical trials.
- Collaboration with clinical operations personnel as well as QA and Regulatory Affairs design and analyze appropriate data sets.
- Development of statistical analysis plan for studies, which will be used in regulatory filings.
- Design, develop and implement various analysis protocols.
- Use the various statistical methods to analyze data to support clinical filings including: Kaplan ¡V Meier, logistic regressions, Fisher¡¦s Exact, and categorical data analysis.
- MS in BioStatistics
- 1-2 years experience in a Pharmaceutical / Biologics environment.
- 2-3 years experience working with Phase 2 & Phase 3 Clinical trial data
- Experience in design of experiments, implementation of control charts, and multivariate analysis.
- Excellent oral and written communication skills.
- Demonstrated expertise in SAS programming.
Human Resources
Biopure Corporation
11 Hurley St.
Cambridge, MA 02141
Fax: 617-234-6830
Email: resume[at]biopure.com
Website: http://www.biopure.com
Discussion forums: Opportunity: CLINICAL STATISTICIAN--Boston, Mass.
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Auto-create CDISC metadata/transfer to define
Submitted by
Nobody
;
posted on
Thursday, January 13, 2005
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Welcome to SapMaker
SapMaker is a tool developed by ClinTrialStat Inc. for making Statistical Analysis Plan (SAP) to fulfill the requirement of agencies for conducting good clinical trials. Window version of SapMaker(single license/ multiple licenses) that can create SAP and related metadata for datasets and transfer metadata to XML document, and create table shells and related SAS program template is available.
Specially, users of SapMaker can automatically create metadata of Operation Data Model (ODM), Study Data Tabulate Model (SDTM), and Statistical Analysis Dataset Model (ADaM), and define.xml document following standards of Clinical Data Interchange Standards Consortium (CDISC).
SapMaker has following features:
Automatically create SAP content text in Microsoft Word document;
Automatically create table shells (mock tables) and mock data listing in Microsoft Word or Excel document;
Automatically create metadata templates of datasets for the created mock table using ODM, SDTM, and ADaM standards of CDISC;
Automatically create metadata templates of datasets customized by users;
Allow users to work on metadata in Excel spreadsheets automatically following CDISC standards;
Automatically transfer customer's metadata of datasets for submission to define.xml metadata document following CDISC standards;
Automatically create SAS template of the mock table or mock data listing;
Included all CIDSC ODM, STDM, and ADaM metadata templates of datasets and more than 300 types of mock tables;
With capacity of managing the creation of SAP documents;
Can be adapted to fit standards of customers;
Allow SAP developer pre-view image of mock tables before creating the mock table.
We understand that individual organizations have their own standards for SAP contents, dataset metadata, table formats, and SAS macros. SapMaker can be easily adapted to standards of individual organizations by modify set-up documents.
If you would like more information, please contact us at clintrialstat@yahoo.com.
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