Pharma job! Senior Clinical Biostatis...
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Jun
25
ragupathyrenganathan
Pharma job! Senior Clinical Biostatistician- New Jersey – New Jersey – competitive
Pharma Job Portal
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  • Job type: Contract
  • Salary: competitive
  • Location: New Jersey
  • Reference: RE-12593103

Responsibilities will include, but are not limited to, the following:

1.Actively provide statistical support to the Clinical R&D Department.

* Provide statistical input into the design of protocols including preparation of the biostatistical analysis section.
* Suggest optimal statistical designs that are acceptable by regulators.
* Prepare statistical analysis plans including table shells.
* Analyze and report results of clinical trials.
* Provide tables, listings and graphs for final study reports.
* Provide ad hoc/data driven analyses.
* Provide statistical input for the preparation of final study reports and other required documents.
* Provide project requirements to programmers and hands on programming when needed.

2.Manage outside CROs and consultants as needed.
3.Provide support to other statisticians when the projects are during the peak time.
4.Work closely with different departments in the company (regulatory, clinical, drug safety, data management, etc.) and provide statistical support for a variety of functional groups.

Skills/Knowledge Required:

* Working experience in oncology drug development: 5 years for Ph.D., 7 years for MS.

* Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.
* Demonstrated skill in the planning, analysis and reporting of clinical trials.
* Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.
* Ph.D. research in Baysian Methodology/Working experience with
* CRM for early-phase oncology is preferred.
* Excellent SAS skills including report generation. Good at R and WinBUGS/OpenBUGS is a plus.
* Knowledge of MS Office products (Word, Excel, PowerPoint)
* Good interpersonal, communication, writing and organizational skills.

To apply contact,

  • Connor Pollack
  • +1 212 707 8499


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