Sr. Principal Statistics

Summary

Job Title: Sr. Principal Statistics

Location: Paramus, NJ, 07652

Job Type: Temporary Assignment

Duration: 6 Months

Work Type: Onsite

Shift: 9.00AM-5.00PM

Pay Rate: $85.00-$90.00/Hr

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.

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 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

Qualifications:

Education Preferred:

• Ph.D or MS in Statistics or Biostatistics

Work Experience:

• 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

Physical and Mental Requirements:

• 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

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

Job Description

Job Title: Sr. Principal Statistics

Location: Paramus, NJ, 07652

Job Type: Temporary Assignment

Duration: 6 Months

Work Type: Onsite

Shift: 9.00AM-5.00PM

Pay Rate: $85.00-$90.00/Hr

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.

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 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

Qualifications:

Education Preferred:

• Ph.D or MS in Statistics or Biostatistics

Work Experience:

• 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

Physical and Mental Requirements:

• 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

TekWissen® Group is an equal opportunity employer supporting workforce diversity.