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May
28
ragupathyrenganathan
Required! Clinical Biostatistician – Connecticut – competitive – Courtesy(Real Staffing)
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  • Job type: Contract
  • Salary: competitive
  • Location: Connecticut
  • Reference: RE-12593107

Job Responsibilities:

* Provide statistical input to study protocols
* Develop statistical analysis plan
* Monitor internal and CRO project activities including timelines, deliverables and availability of resources
* Interpret study results and write (or at least QC and review) statistical summary reports of study results
* Assist in writing relevant sections of the clinical study report
* Participate and contribute to Clinical Development Plan
* Participate in pre-IND and NDA activities
* Contribute to efficient study design, preparing statistical consideration sections and providing input into other protocol sections.
* Prepare statistical analysis plans including table shells.
* Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation.
* Review, synthesize, interpret and report analysis results.
* Provide ad hoc data driven analyses.
* Provide statistical input for the preparation of final study reports and other required documents.

Minimum Requirements:

* Ph.D. degree in statistics

* Minimum three to five years of experience in pharmaceutical or biotechnology industries with broad knowledge of biostatistics. A good understanding of FDA/EMEA guidelines and drug development process is required.

* Demonstrated ability to work independently in project management and decision making

* Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable

* Knowledge of multivariate analyses and Biomarker analyses is a plus

* Be able to effectively communicate his/her ideas and be able to manage programmers in a constructive manner to make other people more effective.

* Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary. This requirement may be waived for research oriented statisticians with demonstrated capabilities of developing and implementing new statistical methods.



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