Senior Biostatistician : Bayesian / Sequential Design

Massachusetts  ‐ Onsite
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Keywords

Description

The senior biostatistician is responsible for maintaining statistical integrity of clinical trials and will be spearheading the writing of statistical protocols, preparingstatistical analysis plans, preparing data deliverablesinterpreting analysis results and reports, and preparation defence presentations and participating in meetings with FDA / regulation agencies.

Essential experience should include,

Having lead a team on clinical research projects and designing clinical trials

Extensive experienceworking with Phase II & III clinical trials across more than one therapy area

Write statistical methods and study protocols

Review and 2nd opinion CRFs ensuring consistency, best practice and to ensure CRFs are adequate to collect relevant data and to meet objectives as per statistical protocol analysis

QC other statisticians and perform statistical clinical study rapports.

Provide statistical support to answer externalpartners and regulatory agency questions, ie investigators and FDA.

PHD is highly desirable however MS will also be considered.

5 + years experience (PHD) and 8+ years MS.

Excellent communication skills and experienceworkingacross cross functional teams i essential

SAS programming

Experience in 2 or more of the following is highly desirable:

Sequential Design, Sample Size Re-estimation, Bayesian Statistics

The senior biostatistician is responsible for maintaining statistical integrity of clinical trials and will be spearheading the writing of statistical protocols, preparing statistical analysis plans, preparing data deliverables interpreting analysis results and reports, and preparation defence presentations and participating in meetings with FDA / regulation agencies.

Essential experience should include,

Having lead a team on clinical research projects and designing clinical trials

Extensive experience working with Phase II & III clinical trials across more than one therapy area

Write statistical methods and study protocols

Review and 2nd opinion CRFs ensuring consistency, best practice and to ensure CRFs are adequate to collect relevant data and to meet objectives as per statistical protocol analysis

QC other statisticians and perform statistical clinical study rapports.

Provide statistical support to answer external partners and regulatory agency questions, ie investigators and FDA.

PHD is highly desirable however MS will also be considered.

5 + years experience (PHD) and 8+ years MS.

Excellent communication skills and experience working across cross functional teams i essential

SAS programming

Experience in 2 or more of the following is highly desirable:

Sequential Design, Sample Size Re-estimation, Bayesian Statistics

To find out more about Real Staffing please visit www.realstaffing.com
Start date
01/0213
From
Real Staffing
Published at
18.01.2013
Project ID:
474745
Contract type
Permanent
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