Principal Biostatistician - FSP

Role Summary

As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies. In this role you will develop and review Statistical Analysis Plans for data presentation, analyses, and provide programming support to your 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 ‚Äì both verbal and written ‚Äì is a must

Skills

• Statistical analysis and programming (SAS)
• Statistical concepts communication
• DMC charter development and committee support
• Protocol and SAP development
• Data standards: SDTMs, ADaM, TFLs
• Project management and mentoring

Education

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

Additional Requirements

• Occasional travel domestic and international as needed