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