Job Overview:
- Lead complex studies such as NDA submission or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
- Perform project management activities for identified projects including resource planning, timelines and milestone management
- Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings
- Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
- Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
- Conduct overall statistical review of TFLs for complex studies prior to client delivery
- Review CRF and other study specific specifications and plans
- Perform complex sample size calculations
- Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant/Statistical Fellows
- Provide statistical input and review of the CSR for complex studies
- Preparation and review of randomization specifications and generation of randomization schedules
- Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
- Present and share knowledge at monthly seminars and /or team meetings and at external scientific meetings and conferences
- Attend bid defense meetings for complex studies such as NDA submissions or complex, multiprotocol programs in order to win new business
- Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
- Represent the department during audits
Education/Qualifications:
- Recommended: Master's degree, equivalent, or higher in Biostatistics or related field
- Minimum Required: Bachelor's degree, equivalent, or higher in Biostatistics or related field
Experience:
Minimum Required:
- 10+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
- Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
- Proven ability to effectively communicate statistical concepts
A good knowledge of the overall clinical trial process and of its application within Labcorp Drug Development - Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
Company:LabcorpLocation:Victoria - British Columbia - CanadaJob Types:Full TimePost Date:January 1, 2022Valid Through:January 31, 2022