Jul 24, 2014

Need - Biostatistician - Berkeley Heights, NJ (Face 2 Face)

Hello Associates,

We currently have a 6 Months Contract opportunity for a Biostatistician with our direct client located in Berkeley Heights, NJ.


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

·         Work under the direction of Medical Affairs Statistics Disease Lead

·         Actively provide statistical support to the Medical Affairs Department

·         Provide statistical support for publications, presentations, posters for medical meetings and any other requests not covered in the clinical study report. This includes data mining, meta-analysis, and support for data-driven analyses.

·         Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters as needed.

·         Provide statistical reviews of proposed design and analysis of protocols for investigator initiated trials.

·         Provide statistical input for design, sample size,protocol, and CRF for Medical Affairs studies.

·         Provide review of statistical analysis plan including table shells, analysis dataset specifications and all deliverables for Medical Affairs studies provided by CRO

·         Manage outside CROs and consultants as needed.

·         Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.

 

Skills/Knowledge Required:

·         Masters or PhD in Statistics with a focus on statistical methods appropriate for clinical trials is essential.

·         3-5 years of experience and demonstrated skill in the planning, analysis and reporting of clinical trials.

·         Experience in oncology trials a plus

·         Good planning and project management skills.  

·         Detailed knowledge of currently accepted statistical methodologies.

·         Excellent SAS skills including report generation. Willingness to be hands-on when needed.

·         Knowledge of MS Office products (Word, Excel, PowerPoint)

·         Excellent communication, writing and organizational skills is essential.

·         Demonstrated ability to work in a team environment with clinicians, clinical monitors, data managers, programmers and medical writers.

 

Please reach me for further  details  @ Jeeva@takesolutions.com, Ph.: 609-720-1002 x 9325

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