Need 6 Clinical Biostatistician in Somerset NJ

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EMAIL;PREF;INTERNET:recruituser@winwiretech.com
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FN:Srikanth Vittal
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Need 6 Clinical Biostatistician in Somerset NJ.

Need Clinical Biostatistician not SAS Guys

 

Long term contract

 

The Big Picture – Top Skills You Should Possess:

 

  • Clinical Data
  • Data Analysis Reporting
  •  

What You’ll Be Doing:

 

  • Perform validation of clinical reports including tables, listings, graphs, and patient profiles developed by statistical programming staff.
  • Validate the statistical models and methods proposed for conducting statistical analysis on clinical trial data.
  • Develop the analysis specifications for projects involving pooling of data from multiple clinical trials.
  • Review and provide input in design of case report forms, development of statistical analysis plan, and data management plans. Review and approve programming specifications developed by programming staff.
  • Provide oversight and monitoring on programming project deliverables and ensure that the staff follows necessary processes while executing the project.
  • Ensure that each statistical reporting deliverable has necessary and sufficient documentation as required from customer specific SOPs and processes.
  • Act as a point of contact from the division to address any customer concerns and work on investigating the quality issues.
  • Act as a liaison between the upper management and project teams and communicate the quality issues in a timely manner.
  • Write statistical reports, develop statistical analysis plans and work as a point of contact in project specific meetings.
  •  

What You Need to Bring to the Table:

 

  • Masters degree in Biostatistics, Statistics, or Mathematics.
  • At least three to five (3 – 5) years of experience in clinical biostatistical and data reporting with a focus on analysis and reporting of clinical data.
  • Experience with statistical methodologies, and data validation, and mining techniques.
  • Strong knowledge and experience of various clinical trial designs.
  • Thorough understanding of clinical data models and safety and efficacy domains in clinical trials.
  • Prior experience in therapeutic areas of Oncology, Inflammation, Infectious Disease, and CNS is strongly preferred.
  • Thorough understanding of the drug development process, clinical trial reporting processes, and experience of data component of drug submission is a plus.
  • Good understanding of ICH guidelines, Good Clinical Practices (GCPs), and 21 CFR part 11 as these relate to the statistical reporting.
  • Prior experience of drug submission or representation in meetings with regulatory authorities is strongly preferred.
  • Strong experience of safety and efficacy reporting. Understanding of clinical data life cycle from data collection to submission.
  • Understanding, knowledge and experience of CDISC data standards and models.
  • Excellent communication, time management, and problem solving skills.

 

Please let me know if you need more information.

 
 
 
Regards,

Srikanth Vittal
WinWire Technologies
+1-408-792-7288
mailto:recruituser@winwiretech.com