Sr. Principal Statistics

Paramus, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 8 days ago

Vacancies: 1 Vacancy

Job Summary

Overview:

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

Job Title: Sr. Principal Statistics

Location: Paramus NJ 07652

Job Type: Contract

Duration: 6 Months

Work Type: Onsite
Shift: 9.00AM-5.00PM

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.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Job Title: Sr. Principal Statistics Location: Paramus NJ 07652 Job Type: Contract Duration: 6 Months Work Type: Onsit...