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Title:Manager, Statistical Programming and Analysis
Location:CA - Brisbane

The Manager of Statistical Programming & Analysis has both administrative and functional oversight responsibilities for Statistical Programming & Analysis staff supporting both development and post marketing projects.

  • Participates in BioMetrics resource forecasting and budgeting activities
  • Develops and leads the Statistical Programmer Analyst recruitment process and participates in broader BioMetrics recruitment activities
  • Develops Statistical Programming & Analysis related SOPs and contributes to developing BioMetrics SOPs
  • Develops statistical programming guidelines and training curriculum
  • Establishes adaptive mentoring and coaching practices for Statistical Programmer Analysts
  • Establishes goals for Statistical Programmer Analysts that align with those of the BioMetrics department and the company
  • Conducts performance evaluations against established goals
  • Builds effective partnerships with cross functional groups within Biometrics, the study team and across BioMarin to ensure that customer/stakeholder needs are met
  • Participates on department special project teams focused on improving business operations and process improvement
  • Makes recommendations for implementing new statistical programming methods and technologies for reporting and managing clinical data
  • Oversees the completion of all assigned projects by identifying and allocating necessary resources and monitoring project status against objectives and timelines
  • Supports staff as necessary to negotiate project timelines
  • Accountable for every aspect of statistical programming deliverables quality
  • Ensures work adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions in all areas of execution
  • Oversees development and management of the statistical deliverables planning and design work
  • Oversees CRO activities and reviews CRO deliverables as necessary

  • Minimum educational experience is a BS in computer science, mathematics, statistics, or related analytic field.
  • Preferred educational experience is a MS in Statistics/Biostatistics/Biometrics or related field.
  • Minimum of two (2) years administrative and/or functional management experience as a manager, supervisor or team lead in a clinical development setting
  • Demonstrated leadership abilities
  • Understanding of budgeting process
  • Experience establishing working relationships with and overseeing vendors
  • Experience establishing partnerships with cross functional groups in a clinical development setting
  • Experience with delegating and overseeing projects and tasks
  • Experience with establishing department and/or project level processes/procedures
  • Experience coaching/mentoring statistical programmer analysts in both behavioral and technical areas
  • A minimum of eight(8) years SAS programming experience in pharmaceutical and/or biotech company
  • Thorough knowledge of clinical operations and data management roles
  • Thorough knowledge of data collection practices and data flow
  • Commanding understanding of the Biometrics role in a clinical trials setting
  • Advanced knowledge of SAS Software including BASE/SAS, SAS/GRAPH and SAS/STAT
  • Other statistical software package (S-Plus, StatXact, etc.) knowledge desirable
  • Demonstrated proficiency in UNIX
  • Intermediate understanding of scripting desirable
  • Intermediate understanding of Internet architecture and web development desirable
  • Intermediate knowledge of Oracle Clinical or other clinical data management software is desirable
  • Intermediate Word, Excel and PowerPoint
  • Intermediate Ms Project desirable
  • Advanced knowledge of regulatory guidelines and the software development life cycle
  • Electronic NDA and/or BLA submissions via eCTD
  • Experience responding to FDA/regulatory requests
  • Capable of managing multiple projects in support of varied customer needs and functions
  • Capable of working on multiple tasks and shifting priorities
  • Motivated and shows initiative
  • Detail oriented
  • Capable of well organized, concise and clear written and verbal communication
  • Capable of clear and effective communications across disciplines
  • Effective at explaining technical concepts to a varied audience in both an individual and group setting
  • Effective presentation skills
  • Access to corporate computer network, Analytic Computing Environment (ACE) and X Windows software.

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