drjobs Sr. Principal Statistics

Sr. Principal Statistics

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1 Vacancy
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Job Location drjobs

Paramus, NJ - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title: Sr. Principal Statistics
Job Location: Paramus NJ
Job Type: Contract

Job Description:

  • The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing regulatory filings and marketing.
  • Review protocol understand study requirements prepare statistical sections design study elements including sample size calculation analysis methods study duration etc.
  • Review CRF database design and edit check specs
  • Review study quality surveillance plan and monitor study conduct
  • Prepare and/or review SAP TFL shells and specifications for variable derivation
  • Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
  • Provide statistical and validation support for statistical analysis analysis datasets and TFL Review study report manuscripts and other documents related to statistics
  • Work on responses to health authorities and execute new analysis required for responses review statistical inputs for regulatory documents
  • Perform other ad-hoc statistical activities as needed
  • Works effectively with cross functional groups study team and vendors. Proactively control and monitor timelines related to statistics and statistical programming
  • Participates in monitoring CRO activities and reviewing CRO deliverables
  • Other duties as assigned

Employment Type

Full-time

Company Industry

About Company

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