Sr. Principal Statistics

PDS Inc, LLC

Paramus, NJ

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JOB DETAILS

SALARY

SKILLS

Analysis Skills, Case Report Form (CRF), Clinical Data Management, Clinical Practices/Protocols, Contract Research Organization (CRO), Cross-Functional, Data Quality, Data Sets, Database Design, Identify Issues, Licensing, Marketing, Regulations, Regulatory Submissions, SAP, Statistical Programming Languages, Statistics, Surveillance

LOCATION

Paramus, NJ

POSTED

30+ days ago

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 isnt checked for what you are looking for or what is required.

PDSINC, LLC is an Equal Opportunity Employer.

About the Company

PDS Inc, LLC

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