Principal Biostatistician - FSP

Role Summary

Principal Biostatistician in a sponsor-dedicated Flexible Solutions business unit. Responsible for development and review of Statistical Analysis Plans for data presentation and analyses, with programming support to a multidisciplinary global project team.

Responsibilities

• Lead complex studies such as New Drug Applications 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 Data Monitoring Committee 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
• Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
• Review Case Report Form and other study specific specifications and plans
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
• 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
• Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
• Represent the department during audits

Qualifications

• Degree in a relevant field such as statistics, biostatistics, public health, etc. Masters degree strongly preferred
• Solid experience (10+ years) of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company
• 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 professional experience with SDTMs, ADaM datasets and TFLs
• Proven ability to effectively communicate statistical concepts
• A good knowledge of the overall clinical trial process
• Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
• Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
• Business fluency in English – both verbal and written

Skills

• Statistical analysis and planning
• Data Monitoring Committee support
• Statistical programming (SAS)
• Communication of statistical concepts
• Protocol and SAP development
• Mentoring and training
• project management

Education

• Master’s degree preferred in statistics, biostatistics, public health, or a related field

Additional Requirements

• Occasional travel to site locations both domestic and international
• Office environment with exposure to electrical equipment; occasional travel