drjobs Remote Sr. Principal Statistics

Remote 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

Sr. Principal Statistics needs Education: Ph.D. or MS in Statistics or Biostatistics

  • Sr. Principal Statistics requires:
    • Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
    • Excellent knowledge of SAS computer package
    • Excellent knowledge of industry standards such as the ICH guidelines CDISC data structures and FDA guidelines
    • Excellent organizational skills time management and ability to meet established deadlines.
    • Excellent communication and interpersonal skills to effectively interface with others
    • Exceptional interpersonal skills and problem-solving capabilities
    • Ability to work independently and collaboratively
    • Ability to provide leadership for the CRO statisticians and statistical programmers

Sr. Principal Statistics duties:

  • 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 a

Employment Type

Full Time

Company Industry

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