Vacancy expired!
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 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, under direction of Statistical Consultants
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 under the supervision of more senior statistical staff
Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
Provide statistic 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-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:
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
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
