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Principal biostatistician

Covance

This is a Full-time position in Montreal, QC posted February 14, 2020.

Job Overview: Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetingsPerform project management activities for identified projects including resource planning, timelines and milestone managementServe as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical ConsultantsLead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticiansPerform complex statistical analyses, quality check statistical analyses developed by other statisticiansConduct overall statistical review of TFLs for complex studies prior to client deliveryReview CRF and other study specific specifications and plansPerform complex sample size calculations under the supervision of more senior statistical staffDevelop the statistical sections of the protocol for complex studies under the supervision of a statistical consultantProvide statistic input and review of the CSR for complex studiesPreparation 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 proceduresPresent and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferencesAttend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new businessAct as Subject Matter Expert and develop or review procedural documents, or work on new initiativesRepresent the department during audits.

Education/Qualifications: Masters degree, equivalent, or higher in Biostatistics or related field Experience: 8+ 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 Covance Clinical Development Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc.

across a variety of trials