Lead Statistician

Lead Statistician Paramus, NJ Job Details Contract $90 - $93 an hour 1 day ago Qualifications Research design Doctoral degree in statistics Document review (document control) Clinical study protocols and reports 6 years Statistics Biostatistics-based research SAS Project timeline management SAS language Database design ICH guidelines Ph.D. in statistics Doctor of Philosophy Team management Scientific protocols Data quality monitoring Master of Science CDISC standards Master's degree in statistics Organizational skills Experimental design Regulatory submissions Data validation Senior level Cross-functional collaboration Leadership Communication skills Cross-functional communication FDA regulations Statistical analysis tools Time management

Full Job Description 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 specsReview study quality surveillance plan and monitor study conductPrepare and/or review

SAP, TFL

shells and specifications for variable derivationWork closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variablesProvide statistical and validation support for statistical analysis, analysis datasets and TFLReview study report, manuscripts and other documents related to statisticsWork on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documentsPerform other ad-hoc statistical activities as neededWorks effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programmingParticipates in monitoring CRO activities and reviewing CRO deliverablesOther duties as assigned Please ensure that candidates meet all requirement below prior to submitting them! Ph.D or MS in Statistics or Biostatistics 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 Ability to work independently and problem-solve Ability to provide leadership for the CRO statisticians and statistical programmers

Pay:

$90.00 - $93.00 per hour

Work Location:

In person