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WHAT
IN
Senior Statistical Scientist
Job
Parexel
US
-
Durham,
North Carolina
Job Code - 2405066
Position - Full Time
Job First Active on: Thursday, November 05, 2009
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JOB DESCRIPTION: Senior Statistical Scientist
Essential Functions
The Senior Statistical Scientist provides expertise and leadership for data sciences activities with a focus on statistics and clinical programming. The Senior Statistical Scientists works independently for strategic and complex statistical analyses in the development, production, and quality control of product development programs and protocols, analysis plans, and reports. A key function is the direction of statistical analysis including statistical programming to support planned data analysis and displays in addition to exploratory statistical modeling. The Senior Statistical Scientist is client-facing, and participates in capabilities presentations, bid defenses, client meetings, and meetings with regulatory authorities.
Responsibilities
' Provide expertise and leadership for regulatory data sciences
' Provide expertise and leadership for development of study documents, including statistical contributions to protocols, statistical analysis plans, programming specifications, mock data displays, data monitoring committee charters and protocols, analysis protocols and analysis plans for integrated analyses including meta-analyses, planning documents for (blind) data review meetings, statistical reports, contributions to clinical study reports, contributions to regulatory submission packages.
' Supervise statisticians including responsibility for performance management and professional development
' Make recommendations to manager for staff assignments to projects consonant with their training and experience
' Participate in the Global Statistics Leadership Team to assure consistency in global operations
' Understand and provide contributions to electronic submissions
' Understand and provide contributions to common technical documents
' Understand and provide contributions to plans for and execution of integrated analysis of efficacy, integrated analyses of safety, and integrated analyses of benefit to risk
' Provide expertise and leadership in specifications and delivery of tables, figures, listings, analyses, and datasets to be submitted to regulatory authorities
' Understand and provide direction for CDISC-compliant data sets and CDASH-compliant case report forms
' Provide expertise in adaptive designs
' Provide expertise in technology-enabled tools for data review
' Provide leadership is providing transparency in data analysis and data conventions for data displays for regulatory authorities
' Meet with potential clients and clients to instill confidence in PAREXEL capabilities to provide statistical operations expertise
' Work with other departments to ensure creative and expert execution of work
' Interact with clients as key contact with regard to statistical and contractual issues
' Work with programmers on generation and QC of appropriate tables, figures and data listings
' Contribute to development of client Proposal documents
' Represent PAREXEL at client marketing and technical meetings
' Proactively participate in and/or lead process/quality improvement initiatives
' Other duties as assigned
REQUIREMENTS - QUALIFICATIONS: Senior Statistical Scientist
Knowledge, Skills and Traits
' Thorough understanding of e-submissions
' Thorough understanding of eCTD
' Thorough understanding of 21CFR parts 11, 54, 56, 312, and 314
' Thorough understanding of ICH guidelines, E-series
' Thorough understanding of regulatory guidances pertaining to electronic submissions
' Thorough understanding of regulatory data sciences
' Thorough understanding of statistical issues in clinical trials
' Thorough understanding of issues related to adaptive trials
' Acquaintance with Bayesian statistics
' Extensive experience with SAS programming required
' Ability to work independently
' Good analytical skills
' Good project management skills
' Professional attitude
' Ability to work with others
Communication
' Address technical issues effectively with written and verbal communication
' Explain biostatistical and technical issues effectively to technical and non-technical staff
Qualifications
Education
' Minimum of Ph.D. in Statistics or Biostatistics
Minimum Work Experience
' At least 12 years experience within the pharmaceutical or other relevant industry is required
' At least 10 years experience supporting pharmaceutical clinical trials and clinical development including strong experience supporting NDAs and equivalent regulatory applications as a statistician and/or statistical programmer
' At least 3 years experience working within a pharmaceutical or biotechnology company
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