Job Description
Job Title: Sr. Principal Statistics
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Location: Paramus, NJ, 07652
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Job Type: Temporary Assignment
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Duration: 6 Months
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Work Type: Onsite
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Shift: 9.00AM-5.00PM
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Pay Rate: $85.00-$90.00/Hr
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Overview:
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TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
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Job Description:
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Summary of Position:
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- 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.
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Duties and Responsibilities:
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- 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.
- Review study report, manuscripts and other documents related to statistic
- 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 assigne
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Qualifications:
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Education Preferred:
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- Ph.D or MS in Statistics or Biostatistics
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Work Experience:
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- 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 Exceptional interpersonal skills and problem-solving capabilities
- Ability to work independently and collaboratively
- Ability to provide leadership for the CRO statisticians and statistical programmers
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Physical and Mental Requirements:
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- Ability to multitask
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communications
- Adapts change, adjust change and grasps information quickly
- Examine and observe details
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TekWissen® Group is an equal opportunity employer supporting workforce diversity.