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Senior Biostatistician

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Planet Pharma

2021-12-03 13:30:03

Job location Dallas, Texas, United States

Job type: fulltime

Job industry: Science & Technology

Job description

Job Summary:

The Senior Biostatistician I will work within the Product Development group to support data analysis and to develop and review of content for Statistical Analysis Plans and protocols.

Responsibilities:

* Develop and review of content for statistical analysis plans and statistical sections of protocols in coordination with designated internal and external scientific leaders
* Review and recommend options for trial design
* Participate as the lead statistical expert on project teams for assigned studies
* Responsible for all statistical aspects of assigned clinical studies
* Review protocols, case report forms, data management plans, sample size estimates, randomization schedules, clinical study reports, and sections of regulatory submissions
* Validate or produce analyses in support of CSRs and other regulatory submission needs
* Work closely with internal and external statistical and programming resources; resolve statistical programming issues related to interpretation of the SAP
* Lead interactions with external vendors such as CROs and statistical consultants for assigned studies
* Develop and review Biostatistics policies, standard operating procedures, and other controlled documents
* Other duties as assigned

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