Labcorp Drug Development Job - 41222853 | CareerArc
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Company: Labcorp Drug Development
Location: Dalian, Liaoning, China
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

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, multi[1]protocol 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:

Master's degree, equivalent, or higher in Biostatistics or related field

Experience:

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
Clinical Development
Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials


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