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/hour We 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.