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Job Details


Sr. Biostatistician
Norwood, MA  Posted: 6/11/2020

Details:

 
A leading Pharma company has an opening for a Sr. Biostatistician and a Principal Biostatistician. 
The Biostatistician is responsible for statistical activities in support of clinical trials, including contributing to the statistical sections of protocols, preparing statistical analysis plans, reviewing and interpreting the analysis of clinical trial data, and QC and validation of results.  Works closely with other Biostatisticians, Programmers, Data Management, Physicians, Clinical Operations, Safety, Regulatory, Research, and other related disciplines.
Primary Responsibilities
•            Oversees production of, or contributes to statistical sections of protocols, clinical study reports, and statistical analysis plans
            Generates or validates sample size/power calculations and randomization schemes
•            Performs quality control checks of SAS code and output produced by Statistical Programmers
•            Performs ad-hoc and exploratory statistical analyses as needed
            Represents Statistics within clinical study teams
•            Works closely with Data Management and Stat Programming, to ensure final databases, analyses, and reports are accurate
•            Participates in other activities and meetings to support Biostatistics and the Development Team as needed
 
Requirements
•     Master’s degree in biostatistics or statistics, with at least 4-5 years of directly related experience in the pharmaceutical industry; Ph.D. with at least 5 years of experience
•     Knowledge of drug development process and regulatory requirements, including ICH/GCP guidelines
•     Excellent verbal and written communication skills
•     Ability to work independently and as a team member
•     Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint), capable of preparing presentation materials
•     Fluent in spoken and written English
Desired Experience 
•         Familiarity with  CDISC-SDTM-ADaM data standard specifications
•         Phase 3 clinical trial experience
•         NDA submission experience; ISS/ISE
•         Proficient in running simulations using either SAS or R
 

Job ID#:

7653

 



 

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