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Updated: July 4, 2009 Your input
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Source -- prochelp@yahoo.com
Updated: December 4, 2008 We need a statitician
Senior Biostatistician
1.0 Typical Responsibilities
1.1 Coordinate statistical analyses and programming activities on clinical trials.
1.2 Facilitate interaction and communication between Biostatistics and other members of the project teams to which s/he is assigned (Clinical, Data Entry, Medical Writing, Data Management, Safety, Project Management, etc.).
1.3 Represent the Sponsor, when required, in discussions and meetings with the FDA.
1.4 Develop study-specific Statistical Analysis Plans based upon the protocol, clinical monitoring plan and Case Report Forms (CRFs) to ensure that the data collected during clinical trials are analyzed using appropriate analyses and are reported to a level appropriate to meet regulatory requirements.
1.5 Coordinate the implementation of Statistical Analysis Plans with the statistical programmers.
1.6 Review protocols for Biostatistics input.
1.7 Perform Sample Size and Power Calculations.
1.8 Conduct statistical analyses and perform SAS programming, as needed.
1.9 Prepare randomizations for clinical trials.
1.10 Write statistical reports and review integrated clinical/statistical reports.
1.11 Review IND/NDA submissions.
1.12 Provide statistical consulting and education to others within ClinDatrix, Inc. and to sponsors.
1.13 Coordinate the development of study-specific standards, conversion procedures and database design with Data Management.
1.14 Maintain complete and auditable documentation of all statistical/programming activities.
1.15 Provide other general duties as required to support the company.
2.0 Qualifications and Requirements
2.1 PhD in Statistics with one to three years experience as a clinical statistician; or a Masters Degree in Statistics with three to five years experience as a clinical statistician.
2.2 One year of project management experience.
2.3 Knowledge of FDA regulations respecting data quality and clinical trials conduct, analyses, and reporting.
Strong written and oral communication skills. Proven leadership skills. Ability to work within a team environment. Ability to manage competing priorities in a changeable environment. Ability to handle stressful situations and deadlines. Excellent interpersonal skills.
Source -- Brian Murphy (brian.murphy@clindatrix.com)

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Last updated: Jul 2, 2009
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