Remote Sr. Principal Statistics
oSr. 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: oReview protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
oReview CRF, database design, and edit check specs
oReview study quality surveillance plan and monitor study conduct
oPrepare and/or review SAP, TFL shells and specifications for variable derivation
oWork closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
oProvide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics
oWork on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents
Employment Type: Full-Time
Salary: $ 66.00 Per Hour
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