Sr. Principal Statistics

Summary of Position: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.

Duties and Responsibilities:

•    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

Compensation: $93/hourWe look forward to reviewing your application. We encourage everyone to apply - even if every box isn’t checked for what you are looking for or what is required.

PDSINC, LLC is an Equal Opportunity Employer.