Principal Biostatistician – FSP
Employment Information
Job Description
Principal Biostatistician leading complex clinical trials across global pharmaceutical companies. Developing statistical plans and providing oversight with a global project team.
Responsibilities:
- Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs
- Perform project management activities for identified projects including resource planning, timelines and milestone management
- Serve as Data Monitoring Committee Support Statistician
- Lead the development of complex Statistical Analysis Plans
- 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
- Preparation and review of randomization specifications and generation of randomization schedules
- Provide mentoring and training to less experienced staff
- 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
- Represent the department during audits.
Requirements:
- 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®)
- SAS proficiency including use of a variety of statistical procedures
- 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.
- 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 – is a must.
Benefits:
- Medical, Dental, Vision, Life insurance
- STD/LTD
- 401(K) retirement plan
- ESPP
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
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