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